S.No

Device Name

Intended Use

1

Abdominal support/belt/binders, reusable

Intended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling. May also make physical activity more comfortable.

2

Abdominal support/belt/binders, single use

Intended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling.

3

Abrasive polishing agent

A substance, or combination of abrasive substances (e.g. silica pumice), intended to be used for cleaning the accessible surfaces of the teeth by polishing. It does not contain medication and used by dental professionals.

4

Absorbent cotton wool

Intended to used for applying medication to, or absorbing small amounts of body fluids

5

Accupressure calf band

Intended to wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome.

6

Accupressure wristband

Intended for the application of pressure to the Nei- kuan (P6) acupressure point on the wrist, the area identified to help relieve the sensation of nausea.

7

Acoustic Stethoscope

A mechanical listening device used for listening to sounds from the heart and lungs and their qualitative assessment.

8

Activated-medium surgical warming blanket

A non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover.

9

Acupressure applicator, reusable

Applied to the skin without insertion into the body to apply pressure and/or friction to acupressure points.

10

Acupressure applicator, single-use

To be used for acupressure treatment at home by applying non-invasive pressure to acupuncture points. Applied to the skin without insertion into the body.

11

Acupuncture unit, home use

It is intended to provide mild and temporary stimulation of accupressure points resulting in improvement of energy flow and overall vitality.

12

Adaptor, light source

Intended to permit the connection of the devices that together deliver light to a work field from a light source.

13

Adaptor, luer

Adapters which connect or stopper enteral feeding tubes.

14

Adhesive felt pad

Intended to offload pressure from ulcer areas, recurrent plantar ulcers, calluses and corns

15

Adhesive plaster (Zinc oxide adhesive plaster)/Tape

It is intended to secure dressings and for strapping on intact skin.

16

Adhesive strip

A flexible strip (of fabric, plastic, paper, or other material) coated on one side with a pressure- sensitive adhesive, typically used to cover or approximate the edges of superficial wounds or fix dressings to skin. The device may include an adhesive pad and have qualities such as waterproof.

17

Adhesive tape remover

Help reduce pain and ease removal of medical adhesives used in stoma care products, dressings and other medical appliances from the skin surface

18

Adult Diaper/Under Pad

Intended to be used by an incontinent patient’s for absorbing excreta (e.g, urine, etc.). It may be intended for home-use or/and hospital settings.

19

Aerosol adhesive for compression garments

A sticky substance that is applied on the skin to anchor compression garments in place.

20

Air cushion/Pressure relief cushions

Intended to relieve pressure on an affected area when a person has hemorrhoids or when he has undergone surgery in the back or buttock area/prevention of pressure sores/ulcers in patients

21

Airway device cleaning utensil

A hand-held device intended to be used to clean an in situ airway device (not disinfection). It can also be used to clean an airway device ex situ (i.e., once it has been removed from the patient).

22

Airway protection face mask

Intended to provide respiratory protection

23

Airway tube forceps, reusable

Used for grasping a tube for its insertion and/or extraction into/from the airways, or for grasping obstructive objects for their removal from the airways.

24

Alarm, bed occupancy

Bed Floor Mat/Crash Mat Alarm/Alert Patient Movement

25

Allergy testing adhesive strip, epicutaneous

A band of adhesive material designed to be used for epicutaneous allergy testing.

26

Alternating-pressure bed mattress overlay, reusable

A pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant’s bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

27

Alternating-pressure bed mattress overlay, single-use

A pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant’s bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a single use device.

28

Alternating-pressure bed mattress system

An alternating pressure system designed to be used on top of a bed to provide therapeutic or protective effect.

29

Anaesthesia instrument table

It is intended as a support for Anaesthesia instruments used during general anaesthesia surgical procedures.

30

Anaesthesia mask stabilizer, single- use

Accessory to anesthesia face mask to assist in locating the mask headgear (strap) to the mask.

31

Anaesthesia tube holder

The intended purpose for this device is for holding and supporting respiration tubing and breathing circuits connected to a patient, to prevent disconnection.

32

Analytical non-scalp cutaneous electrode

Electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring.

33

Analytical non-scalp cutaneous lead

Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG),

evoked potentials (EP), bioelectrical impedance].

34

Anatomical training model

A 3-D printed patient specific model of an organ (e.g., heart, kidney, lung) or bone(s) intended to be used to assist peri-operative anatomical visualisation and surgical treatment planning. It is created using

3-D Printing processes based on patient medical images.

35

Anesthesia face mask, reusable

A device designed to be placed over a patient’s nose and/or mouth to administer anaesthetic gases to the upper airway.

36

Anesthesia face mask, single use

A device designed to be placed over a patient’s nose and/or mouth to administer anaesthetic gases to the upper airway.

37

Ankle binder, reusable

A strip or roll of fabric or plastic material designed to be wrapped around the ankle to help stabilize and support the joint.

38

Ankle cap

Intended to provide mild compression & support to the ankle joint and to manage ankle pain and inflammation.

39

Ankle sleeves/brace

Intended as the external supports to limit certain motions, such as plantar flexion/inversion and manage postoperative/posttraumatic pain

40

Ankle traction belt

Intended to immobilize the ankle and adjoining joints after injury / surgery to support fast healing and prevents further damage and also helps to decrease pain, spasms and swelling.

41

Anterior chamber physical simulator

Designed to mimic the fluid dynamics in the anterior chamber of the eye during priming/calibration of a phacoemulsification system irrigation/aspiration pump.

42

Anterior wedge footwear/Off loading shoes

Intended for offloading the pressure from forefoot to heel after correction of conditions such as Hallux Valgus, Hammer Toes, Tailors Bunions and Ulcers of the forefoot

43

Anti-shock body support/Garment

Intended to prevent excessive blood loss and prevent post partum haemorrhage complications.

44

Anti-tremor gyroscopic orthotic glove

A battery-powered device designed to be worn on the hand/forearm of a patient with hand tremors [e.g., due to Parkinson’s disease, Essential tremor (ET)] to reduce tremors and facilitate activities of daily living using the hand. It is in the form of a glove with forearm sleeve and built-in gyroscopes which generate tremor-countering forces to promote hand stabilization.

45

Arm board pad

It is intended to provide support to the patient’s arm during prolonged surgeries.

46

Arm board, pediatric

This medical device is intended to immobilize and hold steady infants’ limbs when securing intravenous lines.

47

Arm prosthesis socket

A device that fits over the terminal end of a residual upper limb and serves as an interface between the limb and an artificial replacement arm segment (prosthesis).

48

Arm prosthesis, pediatric

Artificial hand or arm prosthesis for physically disabled pediatric patients.

49

Arm/leg procedure positioner padded strap

To protect the patient’s foot/leg in stirrups.

50

Assistive ergonomic chair, electrically-adjusted

An electrically-powered device intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities and to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair

51

Assistive foot-propelled bicycle

A therapy bike designed for children and teenagers with neuromuscular diseases permitting independent mobility, assisting physiotherapist treatments, providing training for support and balance reactions as well as movement coordination.

52

Assistive gripping/twisting tool, reusable

The devices are handheld grips with attached wristbands intended for stimulation of the sensory neuronal network (hand/fingers) as part of therapies for patients suffering from neurodeneration such as ASD, ADHD and Parkinson’s, or other nervous issues.

53

Assistive shoes/boots

It is a shoe attachment that is primarily intended to assist people with Parkinson’s to overcome a symptom called Freezing of Gait (FOG) through visual cueing by providing visual cues in the form of laser lines. It can act as an intervention for falls prevention in the Parkinson’s population.

54

Attention assistive training device

A device designed to be used by a person with a disorder to develop their attention ability to select, focus, control and inhibit.

55

Automated perimeter

Intended to be used to measure the visual field of the eye.

56

Balance/mobility management system

This device uses sensors to determine the centre of pressure and postural sway of an individual during standing for balance management.

57

Bandage scissors, reusable

Heavy scissors for cutting pads, plaster and plastic rail associations.

58

Basket stretcher

Intended to transfer patients in emergency situations such as in the mountains, and marine offshore application.

59

Bed board

A flat, stiff device designed to increase the firmness of a hospital bed’s mattress to provide an appropriate rest surface for the user typically with spinal problems.

60

Bed exit monitor, fall prevention

Intended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

61

Bicycle exerciser

Device is used by patients in a physical therapy setting under the direction of a medical professional for passive, assisted & active training of upper and low limbs during rehabilitation, to improve motor function.

62

Binocular loupes

It is intended for viewing details of objects with some magnification during ophthalmic/dental and other examinations and surgeries

63

Biofeedback system for rehabilitation

A system, comprising of wearable motion capture devices that allows patients with upper and lower extremity movement dysfunction to undertake intensive practice of single and multi-joints using movement biofeedback. The system detects movement and provides this as feedback to the patient. This does not display a quantifiable property in measuring units.

64

Birthing bed/table, non-powered

Intended to be used as a support surface during labor and delivery.

65

Bite block, dental

A non-sterile device inserted into a patient’s mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) and to allow them to bite down on for greater comfort during a dental procedure. This is a reusable device.

66

Bite block, endoscopy

A single use accessory used to protect both the patient and the endoscope, when an endoscope is inserted into a patients mouth for a procedure. It may also be used during other treatments such as intubation of a tracheal tube.

67

Bite block, radiotherapy

Bite Blocks are devices which are used to reproducibly position the mouth, tongue or lips during radiotherapy treatment of the head and neck.

68

Blood/body fluid solidifier

A solidifier substance is intended to be used to absorb and solidify blood and/or other body fluids collected in surgical suction canisters. The substance is often added to the bottle/canister before or after collection of the fluid.

69

Bobath table

Intended for postural exercises, rolling, turning and balance training of patients with loss of sensation or poor balance and other neurological conditions such as stroke, head injury and orthopedic indications

70

Body waste receptacle

Intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

71

Brachytherapy radionuclide phantom, test object

Intended to mimic the functional/physical characteristics of normal or diseased human organs during performance evaluations of brachytherapy system

72

Breast pad

Used to absorb excess milk and protect the breast during nursing.

73

Breathing circuit bag/Reservoir bag

A device intended to store breathing gas during the respiratory cycle.

74

Cable-controlled hand prosthesis

Intended as an artificial hand for physically disabled persons, whose movement can be controlled by a cable

75

Camera cover

Provide an infection-control protective barrier for dental intra-oral camera

76

Camera for dental use

Intended to be used to record that location of posts and or abutments in a lab model or the mouth allowing for a dental treatment plan to be produced during dental implant planning.

77

Camera for medical applications

A camera to be used with microscopes, colposcopes and on endoscopic procedures.

78

Capnography sampling adaptor

The device is intended for sampling CO2 and use with monitors enabled with capnography technology

.

79

Cardiac compression board

A flat, rigid device that is placed under a patient to act as a support during cardiopulmonary resuscitation.

80

Cardiopulmonary resuscitation mouthpiece/cover

A non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator. This is a single-use device.

81

Cast boot/shoes

A boot-like cover for a foot enclosed in a leg cast or bulky bandages intended to support postsurgical healing, injury/trauma care or any situation that requires a pressure off-load of the foot.

82

Cast removal protective tape

To be placed between a cast stockinette and the lining of a cast, along the line where subsequent cast cutting is intended to occur during cast removal, to prevent cuts and burns to the skin caused by the cast cutter/saw.

83

Cast stockinette

Intended to be used with casting material to provide under-cast padding and cushioning.

84

Cast walking heel

A rubber device designed to be attached to or incorporated into a cast to support the patient while walking.

85

Cerebral Cavernous Malformations (CAM) vision stimulator

Intended for stimulation of the eye for treatment of lazy/ambyopic eye

86

Cerebral Palsy (CP) walker

Intended as a walking aid for patients affected by cerebral palsy, for postoperative rehabilitation, polio, and other neurodevelopmental conditions

87

Cervical pillow

Intended to provide support to people who have trouble keeping their spine straight and management of neck/cervical pain

88

Cervical traction head holder/head halter

Intended to be used with cervical traction kit to halt the head for physical support.

89

Cervical traction kit (with/without weights)

Intended for traction of cervical region in conditions such as neck or back pain, post surgery rehabilitation, reducing neck pressure, etc.

90

Cervical traction spreader bar/ Spreader bar

Intended to serve as a component of a traction kit to relieve pressure by stretching the musculature and connective tissue components of the cervical spine.

91

Chair cushion, pediatric use

A supportive seat shell designed for use with a disabled child to allow them to sit independently on a chair/swing/shopping trolley

92

Chair, flotation therapy

Intended to aid in the prevention of pressure injuries as a result of reduced mobility and extended sitting postures.

93

Chest stand

Intended to provide a stable and adjustable platform to position patients for accurate and high-quality chest/full body X-ray examinations.

94

Chest/Limb Restrainer

Intended to stop or limit a patient’s movement

95

Cholera bed

Intended as a physical suppport for severely ill and weak patients including those suffering from cholera

96

Clamp for rubber dam

A dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth.

97

Clavicle support/brace/belt

Intended to support and limit the movement of clavicle bone in case of injury, fracture, post surgery, etc.

98

Cognitive test equipment

Evaluation and training in stereognosis, form constancy, position in space, shape recognition and sequencing as well as teaching compensatory techniques for loss of visual field.

99

Collar and cuff arm sling

Intended to immobilize forearm, elbow, humerus or shoulder injuries.

100

Colour discrimination non- prescription spectacles

A non-prescription ophthalmic device intended for use by people with color blindness to improve color discrimination and blocks UVA and UVB radiation from sunlight.

101

Compression bandage: two component system

Intended for management/prevention of venous insufficiency, chronic oedema, venous ulcers, etc.

102

Compression/pressure sock/stocking applicator

Intended to assist in wearing/removing of medical compression stockings.

103

Compression/pressure tubular garment

To tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema.

104

Conductive abrasive gel for skin preparation

Designed to reduce the resistance (impedance) and defatting the skin in preparation for electrophysiological examinations: electroencephalography (EEG), long-term EEG monitoring, polysomnography (PSG), evoked potentials (EP), stress test ECG, ECG monitoring by Holter in clinics, hospitals, diagnostic centers

105

Conductive electrode gel/paste (adhesive/non-adhesive)

Intended to reduce resistance between skin and electrodes during examinations such as ECG, EEG, EMG

106

Continuous glucose monitor retrospective data analysis software

Intended to analyze and correlate retrospective data from a continuous glucose monitoring device.

107

Controlled ankle motion (CAM) walker

Intended for preventing/limiting foot/ankle movement in cases of serious sprain, surgery or removal of cast

108

Corn/callus dressing, reusable

The device is intended to offer symptomatic relief of physical foot disorders and similar conditions, by providing a mechanical barrier which relieves the effects of pressure and friction and or support.

109

Corn/callus dressing, single use

A non-sterile adhesive dressing intended for protection and/or relief of corns or calluses (hardened areas of skin on the feet or toes).

110

Cotton and rubber elastic bandage

It is and elasticated device intended to be worn on limbs for managements of sprains, strains and painful joints on intact skin.

111

Cotton crepe bandage

It is intended to be worn on limbs for managements of sprains, strains and painful joints on intact skin.

112

Cottonoid pad

A device that is placed next to the parotid gland in order to absorb the saliva that is being secreted. This aids in dental procedures as it helps maintain a working field dry.

113

Cover for thermomete probe

It acts as a physical barrier between the patient and an in-the-ear thermometer to prevent cross- contamination between patients.

114

Cover, dental

To cover and protect a dental handpiece during dental procedures and prevent cross-transmission of infection between patients.

115

CPAP/BPAP chin strap, reusable

A device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed.

116

CPAP/BPAP chin strap,single use

A device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed.

117

Cranial orthosis, pediatric

A patient-matched helmet-like device, intended to be worn on the head of an infant with an abnormal head shape (e.g. due to plagiocephaly, brachycephaly) to improve cranial symmetry/shape during growth over a period of months.

118

Crash cart/Emergency recovery trolley

Intended for use in hospitals for transportation and dispensing of emergency medication/ equipment at the site of a medical/surgical emergency for life support protocols.

119

CT phantom, test object

Intended to establish, validate, and provide for routine and periodic verification of patient imaging CT system performance consistent with internationally recognized standard.

120

Custom-made anatomy model

A model of the bone of a specific patient intended for use to facilitate accurate preoperative planning and introperative placement of a device during orthopaedic surgical procedures.

121

Dental abrasive disk guard

A dental device intended to be fitted around an abrasive disk when rotating at high-speed to protect tissues not intended to come in contact with the abrasive disk.

122

Dental abrasive disk, reusable

Intended for use in contouring, finishing, and polishing dental restorations.

123

Dental abrasive disk, single-use

Intended for use in contouring, finishing, and polishing dental restorations.

124

Dental abrasive strip, reusable

It is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays.

125

Dental abrasive strip, single-use

It is intended to be used for cleanup, polish or finish dental crowns and bridges after cementation of crowns, veneers, bridges, inlays or onlays.

126

Dental amalgam mixer

This is a dental benchtop amalgamator that is intended to mix by vibration/shaking, encapsulated materials to be used for dental restorative procedures in the mouth.

127

Dental articulation liquid

A range of pressure indicating material used to locate areas of denture or removable dental device discomfort in the patients mouth. Used for seating crowns, bridges, full dentures, immediate dentures and partial dentures.

128

Dental articulation paper

Intended for marking areas of contact between opposite teeth, restorations or appliances.

129

Dental automated x-ray film processor

A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practice for the rapid processing of films.

130

Dental cheek retractor, home-use

This is a hands-free, self-retaining frame that is intended for home use by a patient to retract the lips/cheeks to facilitate viewing of the teeth.

131

Dental cuspidor

This is a vessel, e.g. a round bow, into which the patient may expectorate during and after dental procedures.

132

Dental floss

It is a tape/thread-like device intended for removing plaque, food debris, etc. from between the teeth and aid in prevention of dental caries

133

Dental implant abutment analog

A rod-like device intended to be used as a copy of a dental abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental abutment placement; it may be used during a scanning procedure

134

Dental implant abutment impression cap

A device intended to be placed intraorally on the abutment head of a dental implant during dental impression procedures, to facilitate the removal of the impression material after setting and to ensure the position of the implant in order to transfer it to a working model for the dental technician.

135

Dental implant/prosthesis handling forceps

This is a hand-held manual dental instrument designed for grasping and holding a dental devices(e.g., crown, bridge, screw) during its application to a patient’s oral cavity

136

Dental impression adhesive

A liquid material specifically made to give adhesion of an impression material to the impression tray.

137

Dental laboratory CAD/CAM unit

This is a laboratory based device that is intended to be used to aid in the computer-aided design (CAD) and manufacturing/production (CAM) of dental restorations in the dental laboratory.

138

Dental material application tool, reusable

Intended to be used in dentistry for the application of a dental material (e.g., composite resin, etchants, etc.) to a dental prosthesis or to a patient’s tooth/teeth or elsewhere in the oral cavity

139

Dental material heater

Intended to heat regular (paste) and flowable composite material, including bulk fill composites, compules, porcelain veneers and onlays

140

Dental matrix wedge

Used to wedge between teeth to create space when applying restorative materials

141

Dental pick

Intended for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses.

142

Dental precision attachment fitting/adjustment tool

This is a hand held dental laboratory instrument that is intended to be used in a dental laboratory or dental surgery during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments.

143

Dental resin applicator

Intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included.

144

Dental rubber dam

Dental rubber dam is a stretchable sheet used to isolate a field of work from the rest of the oral cavity in dentistry.

145

Dental spatula, single- use

Used for kneading or mixing dental material (impression material, cement, etc).

146

Dental suction system fluid- separation unit

A separator used in the oral cavity for the separation of fluids (saliva, blood) from gases to avoid liquids from entering the suction pump (i.e., dry

suction).

147

Dental surgical microscope

This is a dental device that is intended to be used to magnify and visualize minute intraoral structures during dental examination and dental surgical procedures in the mouth.

148

Dental torque wrench adaptor

It is used to enable connection of the main body of the wrench to a specific endpiece(s).

149

Dental X-ray beam aligner

Intended to assist the dental radiographer position the positioning indicator device relative to the tooth and receptor

150

Dental X-ray film holder

It is used to hold the dental xray films and position it to the right angle inside the mouth to aim taking an accurate xray

151

Dental/oral lavage unit (water flosser)

Intended to inject a stream of water on teeth to remove dental plaque in between teeth and improve gum health. It is intended as an OTC (home use) device.

152

Dental-professional prophylaxis brush/Dental polishing brush

A rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth.

153

Dentifrice

Prophylaxis pastes without fluoride intended to be used by professionals for tooth cleaning and polishing procedure by abrasion/mechanical cleaning only.

154

Dentures cup

This cup is intended to hold patient dentures when they are not in the mouth.

155

Dermatoscope

Intended for non-invasive, visual inspection of intact skin by a healthcare professional.

156

Derotation bar with Traction

Intended for lower limb traction and aid in early healing, correction of drop foot

157

Diagnostic X-ray system positioning frame

Diagnostic X-Ray System positioning frame

158

Dialysis bag clamp/clip

Intended to be used for opening or closing the dialysis tube.

159

Dialysis set holder

To hold and secure in position a dedicated set being used during a dialysis procedure.

160

Digital examination camera

Digital camera for close-up skin inspections or general examinations.

161

Direct ophthalmoscope eye cup

The device is intended to be attached to the distal (patient-contact) end of a direct ophthalmoscope head to facilitate appropriate positioning around the patient’s eye socket during an examination.

162

Disability vehicle, moped

A moped that provides mobility to a disabled person

163

Disposable Kelly pad

Intended to funnel blood to a collection device in order to help detect postpartum hemorrhage

164

Dissection board

A device on which an object is placed for support during dissection procedures

165

Douche kit

A packaged collection of items (douche solution prefilled in a douche unit) used to provide cleansing of the vaginal area of the user’s body.

166

Drainage tube

A hollow device used as a conduit to remove fluids or purulent material from a cavity, wound, or infected area.

167

Drape adhesive

Intended to be placed on the skin to attach a surgical drape.

168

Dressing retention garments

Intended for use in wet and/or dry wrapping and dressing retention in the treatment of atopic eczema.

169

Drying chamber for breathing circuits

A chamber designed for drying breathing circuit equipment.

170

Ear Irrigation kit

Irrigates the ear canal with solution to clear wax and debris.

171

Elastic adhesive Bandage

It is intended to secure dressings and for strapping on intact skin

172

Elasticated cohesive Bandage

It is intended to secure dressings and for strapping on intact skin

173

Elbow immobilizer

A non-rigid external device, usually made of a fabric, used to temporarily render the elbow immovable to support healing of an injury or a surgical wound.

174

Electric dental chair without operative unit

A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit.

175

Electric stander

Standing frames for those with standing difficulties

176

Electric toothbrush

Intended to remove plaque, tartar, food debris, etc. from teeth and gums and aid in prevention of dental caries, etc.

177

Electrical-only medical device connection adaptor

This device connects incompatible plugs/sockets on related medical devices (e.g., video control centers, peripheral devices and controller) and/or cables and relates the control signals.

178

Electrosurgical electrode holder

A device intended to be used to house active hand- controlled electrosurgical electrodes (pencil electrodes) when not in use during the surgical procedure.

179

Emesis bag

A disposable device intended to collect and contain a patient’s vomit and eliminate exposure to vomit until it is convenient to dispose of the bag and its contents.

180

Endaural wax extraction curette

This device is intended to simply extract ear wax using a soft silicone tip that expands in ear cavity to aid extraction.

181

Endoscope calibration cover, reusable

A plastic cap/cover designed to be placed onto the distal end of an endoscope to allow white balance and/or 3-D adjustment to be calibrated in the electronic control unit of the endoscope. This is a reusable device.

182

Endoscope channel cleaning valve

An adapter or valve to be fitted to an endoscope for cleaning purposes

183

Endoscope cleaning brush

A device used to remove dirt or debris from the working channel (s) and irregular surface of the endoscope prior to disinfection and sterilization.

184

Endoscope collector

A device intended to collect the excreted endoscopic video capsule camera.

185

Endoscope flushing adaptor, single- use

An adapter intended to be fitted to an endoscope air/water channel for flushing of the endoscope during post-procedural ‘precleaning’ step of endoscope reprocessing after endoscopic procedure.

186

Endoscope leak tester tubing

Leak tester tubing for use during endoscope leak test.

187

Endoscope/instrument holder, manual-adjusted

A manually adjusted device intended to be used to hold, maintain in a desired position, and enable positional adjustment of an endoscope (e.g., laparoscope) and/or associated instruments/devices during an endoscopic examination/surgical procedure.

188

Endoscopic irrigation/aspiration foot- pedal

A manual, foot-operated device intended to be used in conjunction with an irrigation tubing set to facilitate delivery of sterile irrigation fluid.

189

Endoscopic video image interpretive unit

The device is intended to be used by trained clinicians as an adjunct to video Endoscopy for the purpose to highlighting regions with visual characteristics consistent with different types of mucosal abnormalities.

190

Endoscopic video image processor

A unit designed to receive the electronic signals sent from a video endoscope and may/may not compensate for/enhance the colour and light qualities provided.

191

Endotracheal tube holder

Intended to provide a reliable stabilization of endotracheal tube after intubation

192

Enema bag

Intended to be used to hold an enema solution for administration into the rectum

193

Enteric stomal shield

A non-sterile cap intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction).

194

Enuresis alarm

The device that activates a signal when a small quantity of urine is detected by a sensing mechanism to help a child with training the bladder.

195

Epileptic seizure alarm

Intended to alert or notify healthcare professional or next of kin when an epileptic patient (often pediatric) gets a seizure attack.

196

External lower-limb prosthesis socket

A component of an external lower limb prosthesis designed to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension.

197

External silicone breast prosthesis

Intended to restore normal contour and improve function for patients who have experienced partial or total loss of their breast to traumatic injury, disease or due to surgical removal of the nose (rhinectomy).

198

Extractor

Used to aid in the removal of foreign objects from superficial skin tissue.

199

Eye pad, non sterile

Intended for use as a bandage over the eye for protection or absorption of secretions.

200

Eye patch, non-sterile

A device with a synthetic origin used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention.

201

Eye patch, non-sterile

Intended to provide temporary occlusion for the eye in the treatment of Amblyopia, diplopia or as a occluder for vision or field testing.

202

Feeding nipple

Intended for use as a feeding nipple for infants with oral or facial abnormalities

203

Fiber cast bandage

Intended to be used as a medical dressing made of synthetic materials to support and protect bones that have been broken or joints that need stabilization.

204

Filter for dental suction equipment

Filter that ensures debris does not enter dental suction equipment

205

Filter for gas central supply system

Designed to remove particulates and volatile organic compounds (VOCs) from the gas flowing into incubators used in IVF procedures.

206

Finger and toe bandage

An elastic, tubular device intended to be worn over/around the limb

(arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury.

207

Finger Cot/brace

Intended to support, align, prevent or correct deformities/injuries or to improve function of finger

208

Finger/hand exerciser

Intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density (post fracture/stress/weak forearm and grip strength).

209

Flatus tube, single-use

A soft and pliable tube intended to be inserted through the anus to relieve colic in infants. It is a single-use device.

210

Flex bar

Intended to increase tendon strength and reduce elbow pain for those who suffer from tennis and golfer’s elbow.

211

Fluid delivery mount, general- purpose

The device is designed to hold the fluid bags when gravity irrigation is needed for scope surgery.

212

Foot traction kit

It is used in relieving pain due to muscle spasm, maintaining the limb in a position of comfort and to restore and maintain the alignment of bone due to fracture or dislocation.

213

Footstool, conductive

A low stool for standing on to compensate for height differences. It is intended to be used in, e.g. examination rooms or operating theatres.

214

Forceps, dressing

A surgical instrument with scissor like handles used to grasp dressings, e.g. cotton swabs, towel, lints

215

Forceps, sterilizer transfer

Forceps with specially designed blades used to handle sterile instruments or implants.

216

Fundus camera

It is intended to capture and document digital images of the posterior and anterior segments of the human eye.

217

Fundus camera, pediatric

Intended to capture digital color images of the retina of infants having less than 55 weeks of Post Menstrual Age (PMA), while there eyes are dilated using mydriatic drops under clinical control.

218

Gait rehabilitation electronic walker

A mobility and transfer device that helps a health care professional raise a patient to a standing position, providing support for standing or ambulation, or lifting a patient in the seated posture and transferring them between wheelchairs, chairs, toilets, beds or therapy tables.

219

Gait Trainer

It is used to assist and train a person with physical disabilities to relearn/improve walking.

220

Gait trainers-Unweighing System

Intended for partial weight-bearing therapy in rehabilitation

221

Gas sampling line filter, reusable

The device is indicated for adult, pediatric, infant/neonatal patients for removal of moisture from the gas sample.

222

Gastric pH strip

pH strips to indicate the pH level of human gastric aspirate

223

Gel base for metallic neuro head frame

It is used for providing support patient’s head in a suitable and stable position (e.g., supine, lateral, or prone) during intracranial and spinal surgeries.

224

Gel knee ring

Intended to be worn around the knee for pain relief and immobilization

225

Gel-filled bed mattress

A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores.

226

Gel-filled bed mattress overlay

A gel-filled pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant’s body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores.

227

Gel-filled chair cushion

A gel-filled pad designed to be placed on the seat of a chair to distribute an occupant’s body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores.

228

General-gas low pressure tubing, reusable

Intended to enable nitrogen or instrument air to be delivered to the console from the wall in the hospital.

229

General-purpose diagnostic x-ray phantom, anthropomorphic

A device that consists of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue- equivalent model designed to mimic the functional, physical, or a combination of these characteristics of a normal or diseased human organ or organ systems. It is a quality assurance (QA) device intended to permit both subjective and quantitative evaluation of the overall function of both conventional and digital general-purpose x-ray systems and associated image acquisition, display and analysis computer programs.

230

General-purpose diagnostic X-ray phantom, test object

Intended to provide for routine and periodic verification of the energy, hardness and intensity of an X-ray beam

231

General-purpose diagnosis/treatment table

Intended for use in general diagnosis and procedures in examination room to aid patient examination.

232

Gingival barrier (non-medicated)

Intended for protection of gingival area during tooth bleaching process

233

Gonio lens

Intended for viewing the anterior chamber angle and retina

234

Grip-enhancing exoskeleton

Intended to improve grip strength and hand function for people (from children to elderly people) with impaired hand function. The condition may be (but is not limited to) due to orthopaedic or neurological problems, from birth or acquired. The device mimics the user’s grip movements and supports the users’ natural grip.

235

Gynaecological operating table, electrohydraulic or electromechanical or hydraulic

Intended to support a patient during gynaecological surgical procedures

236

Gynaecological examination/treatment table

Intended to support a woman’s body in the appropriate positions during gynaecological examinations.

237

Hallux valgus metatarsophalangeal orthosis

A prefabricated (non-customized) non-rigid, home- use device intended to be worn on the foot to help prevent and/or reduce hallux valgus deformity, thereby reducing walking pain and bunion formation.

238

Hand exerciser table

This modality exercise is meant for rehabilitation of the hands, fingers, and wrist disorders injuries & fractures.

239

Hand-carried stretcher

Intended to carry patient as an assistance for injury or disability.

240

Handgrip cover for laryngoscope

Intended to be placed over the reusable laryngoscope device during intubation to create a barrier in order to reduce the cleaning time and turnaround time of the laryngoscope blade for reuse.

241

Handgrip cover for surgical light

Intended to provide physical barrier on a handgrip to prevent cross-contamination between the operating room surgical lights (non-sterile) and the operating room personnel.

242

Handgrip cover for vein illumination device

The cover is intended to isolate vein illumination devices and simplify cleaning after use.

243

Head marking cap

A head covering designed as a cap intended to be worn on the head of a patient to allow a healthcare professional to mark specific reference points on the head during a procedure [e.g., transcranial magnetic stimulation (TMS)] as an alternative to marking the scalp directly or to avoid cutting the patient’s hair.

244

Head reflector

A head-worn device consisting of a circular concave mirror (reflector) attached to a headband designed to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient.

245

Head Rest/Ring

Intended to position and protect a patient’s head, face and neck during prolonged surgeries

246

Heal cushion/Spur pad/cup

Intended to worn on the heel to relieve heel pain, plantar fasciitis, foot pain, pain during walking, calcaneal spur, sprain and strain of the foot, ankle, feet and knee pain.

247

Heat-sealing device

Intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

248

Hip pad positioning device

It is used to support the patient hip during prolonged surgeries.

249

Hip protector (Belt)

Intended to be worn by older adults or patients who have balance/vision problems, bone conditions, or at risk of falling to prevent hip injuries and fractures.

250

Hip shield

A mechanical guard worn over the hip to reduce risk of injury in the case of a fall

251

Hospital Backrest

Intended to support patients with spinal problems and pain management

252

Hydraulic/pneumatic external knee prosthesis

This device is intended for transfemoral amputees, is a prosthetic device designed to restore some function of an anatomical knee joint.

253

Hydrocollator pack

Intended to be applied to the body surface to provide heat therapy to reduce muscle spasms and cramps and/or for joint/muscle stiffness and pain

254

Hydrotherapy equipment/tank

Used for rehab treatment requiring resistance created by water to aid in injury recovery, improve blood circulation, and decrease inflammation, speeding recovery time

255

Hypothermia-prevention cap

Intended to prevent heat loss from the patient’s head

during surgery and under anesthesia.

256

Image display monitor mount

A dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor, can be placed and secured so that it is safely mounted in a position suitable for viewing. manufactured for hospital use.

257

Infant acoustic earmuffs

A device consisting of two ear-covering cups (one for each ear) intended to provide noise insulation for neonates/infants in a special care unit.

258

Infant cap

To be used with an infant nasal CPAP respiratory support breathing system to act as a stabilizing head strap.

259

Infant oral pacifier

To be used to calm the premature infant for longer duration specifically during Nasal CPAP or when infant is intubated and on mechanical ventilation. For hospital use only.

260

Inflatable hot/cold therapy pack/manual pump

A non sterile assembly of devices that are intended to be applied with pressure to a body surface to provide cold or heat therapy to that surface and/or underlying tissue, e.g. the muscle. This device typically consists of a cold/heat therapy pack, air inflation sleeve and a manual air pump with connection tubing. It is reusable and intended in both the professional and home setting.

261

Inflatable limb splint

A sleeve placed around an arm or leg and inflated to immobilize the limb.

262

Inflatable patient transfer sliding mattress, single-use

An inflatable device designed to support a recumbent patient on a bed or table and assist in the physical movement of a patient for safer, easier transfer and positioning in Trendelenburg and Reverse Trendelenburg.

263

Infusion line clamp

A device intended for the clamping of medical tubes.

264

Infusion line securement clip, single- use

The device is intended to hold tubing to avoid kinking of the tube during infusion and patient moving.

265

Inguinal hernia belt (Adult)/surgical truss, reusable

A reusable device Intended to relieve discomfort and hernia pain caused by an inguinal or sports hernia

266

Inguinal hernia belt (Adult)/surgical truss, singe use

A single use device intended to relieve discomfort and hernia pain caused by an inguinal or sports hernia

267

Injection site desensitizer, tactile

A non-sterile, noninvasive reusable device intended to be used to manually apply tactile pressure stimuli to a skin-surface injection site, prior to/during injection, to reduce the pain/anxiety/stress associated with injecting.

268

Instrument lubricant

Intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument)

269

Integration Unit for Flat panel x-ray detector

A portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components.

270

Intestinal ostomy base plate

The base plate is intended to fix the ostomy bag and adhere to intact skin around the stoma.

271

Intraoperative chest positioner

A preformed reusable pad designed to be attached to an operating table for stabilizing a patient’s chest to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures

272

Intravenous access monitoring system, line-disconnection

An alarm system that connects to a sensors around/on a venous puncture site dressing or catheter connection to detect blood or disconnection of the catheter.

273

Intravenous catheter holder, non- sterile

It is a skin adhesive device for the securement of urinary catheters and medical tubing as part of ongoing catheter care.

274

Intravenous hanger, wall-mounted

The device is intended to be used within the medical application to hold infusion bags within the approved load range.

275

Irrigation kit

To irrigate the nasal passages of infants and young children.

276

Irrigation tip, surgical mist

A device that is designed to connect to an air/water syringe to blow a mixture of air and/or water into a patient’s mouth during dental procedures.

277

Jaw exerciser

Hard gum is used to exercise jaw muscles for temporomandibular disorders, increased saliva production, helping to improve efficient food chewing and swallowing.

278

Kinesiology tape

used to support and relieve pain in muscles, joints, and/or ligaments. It reduces swelling, increases mobility and enhances recovery.

279

Knee cap/brace/wrap

Intended to limit the mobility of the knee to relieve pain in conditions of arthritic pain, ligament/muscle injury, surgical procedures, fractures, sprains, etc.

280

Knee ice wrap

Intended to relieve pain, swelling and inflammation in the knee due to ACL, arthritis, sports injuries, sprains, strains, muscle fatigue and surgery.

281

Knife handle

A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade.

282

Knife sharpener

A device used to create or re-establish a thin, keen edge or fine point on an instrument used to cut, such as a knife

283

Laparoscope laser adaptor

Intended to connect the laparoscope to the laser or the laser arm for laparoscopic laser treatment.

284

Laparoscopic surgery handle

A manually operated handle of various configurations to hold instruments used in laparoscopic surgery.

285

Laparoscopic tray

Intended for holding laparoscopy instruments during a laparoscopic intervention or sterilization.

286

Laser protection eyewear

Intended to be used by the staff in an operating or treatment room where a laser is being used, in order to protect their eyes from injury during the laser surgery.

287

LED transilluminator

Intended to provide optimal LED light in the incubator

288

Leg intraoperative repositioning support

A mechanical device intended to be used to help support the weight of a patient’s leg when the leg needs to be repositioned during an orthopaedic procedure. It is designed to be attached to the operating table.

289

Lens system, high magnification

A device (lens) used to observe the retina or anterior chanber of the eye.

290

Lice comb

Removes head lice eggs and nits and can be used in conjunction with all lice treatments

291

Limb/torso/head restraint, reusable

The devices are designed to position and support patients in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery during Reverse Trendelenburg positioning.

292

Liquid barrier dressing, dental

Protection of gingival area during tooth bleaching process

293

Lower limb exerciser

Intended to provide above and below knee amputees the ability to improve muscle and strengthen residual limbs

294

Lower limb sliding exerciser, non- powered

A non-powered device intended to encourage active movement of a patient’s lower limb(s) by assisting flexion/extension at the knee for rehabilitation. This is a reusable device.

295

Lower-limb orthosis

The device is an externally-applied wearable appliance intended to support and correct deformities of the leg and/or feet. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single- patient reusable device.

296

Lower-limb warming sock/stocking, single-use

Intended to prevent heat loss during surgery and under anaesthesia. The patient’s lower extremity is placed in the legwarmer which is equipped the same way as socks.

297

Magnetic field shielding material for cochlear implants

An accessory intended to be used on Cochlear implant recipients to prevent implant magnet dislodgement during MRI scans. The device is placed externally on the recipient’s head by a healthcare professional prior to undergoing an MRI procedure.

298

Mammographic x-ray phantom, test object

A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of dedicated digital or conventional diagnostic x-ray mammography systems or general-purpose x-ray systems adaptable for mammography applications.

299

Mammographic x-ray system compression paddle

A mechanically, electronically or software-controlled component of a mammographic x-ray system used to flatten and stabilize the breast during mammography studies or mammography system- guided biopsy procedures.

300

Mandible-repositioning sleep- disordered breathing orthosis

A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position.

301

Manual adjustable hospital bed

Intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed.

302

Manual dental burnisher, reusable

Used to polish the surface and smooth the margins of restorations during dental procedures.

303

Manual dexterity assessment software

The software is intended to detect micrographia (smallness of writing), bradykinesia (slowness of movement) and tremor with the

help of an off-the-shelf tablet and a digital pen. This is not intended for self-assessment.

304

Manual dexterity test

Dexterity devices intended to evaluate motor coordination, depth perception and eye-hand coordination.

305

Manual stander

A manually-powered, mobile device designed to support and lift a disabled patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is not intended to facilitate gait.

306

Manual toothbrush

An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains, etc) and/or aid in prevention of dental disorders such as caries.

307

Manual wheeled stretcher

Intended to transport patients in a horizontal position as an assistance to injury or disability.

308

Manual-aperture-control diagnostic x-ray system collimator, non- motorized

A standard, non-motorized, diagnostic x-ray beam- limiting device whose aperture size/length/shutter assembly must be manually adjusted in order to match the size of the x-ray beam to the size of the x- ray cassette in use. An x-ray collimator is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.

309

Marker, dental use

This device range helps mark plaque areas on a tooth and is thus intended to be used to aid disclose/make marks that allows identify dental plaque.

310

Mask strap

A head strap used to hold and stabilise a CPAP or BiPAP face mask onto a patient’s face.

311

Maternity belt

It is used to support the belly bump during the different prenatal periods to avoid forward & downwards stomach pulling, provide maximum support and relieve back & pelvic ache.

312

Mechanical dental chair without operative unit

Intended to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It does not include operative unit.

313

Mechanical-resistance external ankle-foot external prosthesis

External prosthetic components for the purpose of replacement for a foot/ankle. The foot/ankle is intended to be used for a lower limb external prosthetic system

314

Mechanical-resistance external knee external prosthesis

An externally applied component for use in replacement of the knee joint (or other) in persons with limb amputation or difference.

315

Mechatronic external ankle-foot prosthesis

The device is intended as a part of an external prosthetic system that replaces the foot and ankle function of a missing lower limb.

316

Medical compression stockings

Intended for management/prophylaxis of leg pain, deep vein thrombosis, varicose veins and related complications

317

Medical equipment drape, single- use, non-sterile

A flexible polymer sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment such as intra-oral cameras and its equipment components. It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover.

318

Medical examination light (AC powered or Battery)

Intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

319

Medical image printer

A non-invasive, reusable printer that produces hard copies of medical video images.

320

Medical imaging recorder

A non-invasive, reusable electrically powered device designed to be used in conjunction with video endoscopes, and/or surgical video imaging devices to digitally record video images.

321

Medical instrument cable/lead

A reusable cable that functions as a conductor between power source and the medical instrument used for the purpose of transmitting an energy that may, or may not, contain information.

322

Medical print paper

Thermal paper to be used to produce hard copy of printed data generated by a medical device. For recording the EEG,ECG, EMG output from the ECT device.

323

Medical support stocking

Intended to be worn on the upper or lower extremity to support, correct, prevent deformity, or to align body structures for functional improvement.

324

Medical x-ray film, non-screen

A non-screen x-ray film specifically designed for use in medical imaging applications. Non-screen x-ray film is designed for direct exposure to x-rays and is relatively insensitive to the visible light emitted from screens.

325

Medical/cadaver body bags, non sterile

Intended for transporting a human corpse without any spread of biohazard/infectious agent.

326

Medical/Orthotic insoles

Intended to be worn inside shoes/footwear to relieve heel pain, plantar fasciitis, foot pain, pain during walking, calcaneal spur, sprain and strain of the foot, ankle, feet and knee pain.

327

Medicine cup

A specially designed cup used by the nursing staff when they are administrating tablets or pills to patients. It may be used both for tablets and fluids.

328

Meibomian gland camera

It is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

329

Meibomian gland expressor/evaluator, manual

A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) to treat dry eye syndrome.

330

Metatarsal pad

Intended to relieve chronic metatarsal pain, corns, hard skin, morton’s neuroma, forefoot soreness, and painful balls of the feet.

331

Micropore tape

Intended for dressing retention on non-flexing areas and may also be used for patients who have exhibited an adverse reaction to adhesives based upon zinc oxide, rubber, or resin.

332

Microscope cover

This is a device which is usually shaped to fit the surgical camera/microscope that is intended to be used as a physical barrier to prevent cross- contamination between staff or patients during examination.

333

Moist-cold pressure bandage

A pressure bandage intended to provide a cool and to compress a local area of the body.

334

Moldable splint

A moldable splint device that is intended for use as an immobilization of non- or minimally displaced wrist fractures, contusions, and sprains

335

Mouth gag

To be used in dentistry to be placed between the teeth of a patient in order to maintain an open oral cavity during dental procedures.

336

MRI enhancement padding

Dielectric pads that are intended for use with magnetic resonance imaging systems to aid in body positioning and help reduce shading artifacts associated with the air/tissue interface during abdominal, pelvic, and neck imaging.

337

MRI examination catheter holder

The device is intended to be used with ICP catheter kits to enable the catheters to be left in during MRI scanning.

338

MRI phantom, test object

Intended for both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging systems and associated image acquisition, display, and analysis computer programs.

339

MRI system chair

A chair or stool specifically designed to support and position a patient during examinations involving the use of a diagnostic magnetic resonance imaging (MRI) system. For MRI system compatibility these chairs/stools are made of ferromagnetically inactive materials.

340

Multi-chamber venous compression system garment, reprocessed

Deep Vein Thrombosis (DVT) Garments are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. When coupled with an appropriate inflation system, garments are intended for use in preventing deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency.

341

Multi-modality therapeutic radiation phantom, test object

This device is intended to establish and provide for routine and periodic verification with use of target motion of patient dose and machine output in therapeutic radiation oncology system performance.

342

Multiple spinal region orthosis

This is a body worn device that is intended to provide full circumferential containment when reduction in gross spinal

motion about the lower thoracic and lumbar spine is required. This may include post operative spinal stabilisation, fracture and related soft tissue injuries

343

Nasal aspirator, manual

A portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing.

344

Nasal Irrigation kit

To cleanse or flush the nasal passages and sinus cavity with saline for postoperative, preventive, or symptomatic nasal care.

345

Nasal scissors

A surgical instrument used to cut tissue during surgery on the nose and its associated structures. It comprises two pivoted blades usually provided with finger and thumb holes. The distal end of the blades may be different shapes.

346

Nasogastric tube holder

This device is intended to secure nasogastric tubes to skin near and around the nose.

347

Nebulizer tubing set

A device intended to be connected to a nebulizer and transfer medication from the nebulizer to the patient with respiratory disorders.

348

Needle guard

Intended to encapsulate needles withrawn from vein or fistula thereby aiding in the prevention of needle stick injuries.

349

Needle holder

Intended to secure needles during suturing.

350

Needle holder, ophthalmology

It is intended to hold needle for procedure during eye surgeries.

351

Neonatal eye pad

Used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

352

Neurosurgical chair

Intended to support and position a patient in a sitting or

reclined position during neurosurgery.

353

Neurosurgical headrests

Intended to support the patient’s head during a surgical procedure

354

Nipple shield

Intended to aid infants with trouble latching onto the breast by acting like a longer, firmer nipple

355

Nonpowered flotation therapy mattress

Intended for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores).

356

Nuclear scanning bed

A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.

357

One-piece urostomy bag

The ostomy bag is intended to collect output from a stoma. The adhesive is intended to fix the bag and adhere to intact skin around the stoma.

358

One-piece urostomy bag, open- ended

The product is intended for the management of stomal output.

359

Operating room shoes cover, non- sterile

Intended to be worn by operating room personnel during surgical procedures to protect foot of both the surgical patient & the operating room personnel from transfer of micro-organisms, body fluids, and particulate material.

360

Operating table traction frame

Designed to position, support and/or distract the patient’s hand, wrist, forearm and arm in a variety of surgical procedures including, but not limited to arthroscopic or Orthopedic surgery.

361

Operation theatre pendant

Intended to provide ergonomic solution for the positioning and management of medical devices, equipment, and utilities during surgeries and other medical interventions

362

Ophthalmic equipment stand

It is used to keep the ophthalmic equipment like Slit Lamp, Keratometer, Laser etc.

363

Ophthalmic implant handling forceps, reusable

A reusable instrument used to grasp and manipulate ophthalmic implants (excluding sutures) during a surgical procedure.

364

Ophthalmic surgery fluid collection bag

A fluid collection bag connected to a surgical system, used to catch aspirated material during an ophthalmic surgical procedure.

365

Opthalmic examintaion station

A device assembly intended to provide complete ophthalmic examination position and support conditions for the patient and clinician

366

Oral care swab

A foam headed oral swab impregnated with a sodium bicarbonate cleaning solution designed to be used wet to clean the teeth and oral cavity.

367

Oral exerciser

A device that is used to exercise tongue muscles as part of oral myology physiotherapy

368

Orthodontic aligner/retainer seater, reusable

A small cylindrical device intended to aid in positioning and seating an orthodontic progressive aligner or teeth retainer into place. This is a reusable device intended for single-patient use.

369

Orthodontic band pusher

A hand-held dental instrument designed for positioning and adapting metal bands on teeth in orthodontics.

370

Orthodontic positioner support kit

A collection of devices intended to be used to facilitate use of an orthodontic teeth positioner, including placement, removal and cleaning.

It typically consists of an orthodontic appliance remover, an orthodontic positioner seater, and an orthodontic appliance cleanser. The positioner is not included. This is a single-patient device.

371

Orthodontic resin positioning tray

A custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light-cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing.

372

Orthodontic spring

The intended purpose of the orthodontic spring is to open and close space between teeth.

373

Orthodontic vibrator

Orthodontic predictability enhancement device designed to maximise the accuracy of fit and effectiveness of clear aligner treatment.

374

Orthopaedic bone pin holder

A non-sterile stainless steel cylindrical device intended to temporarily hold one or more orthopaedic pins (e.g K-Wires) during sterilisation & surgical procedure against damage.

375

Orthopaedic countersink

used for bone preparation to enable the placement of gingival part of components during dental procedures in the mouth.

376

Orthopaedic instrument extractor

A reusable surgical instrument designed to extract another orthopaedic instrument during an orthopaedic surgical procedure.

377

Orthopedic cast padding

It is intended to protect long prominences under the plaster on intact skin .

378

Orthopedic walker shoes/boots/Air cast boots

Intended for the treatment and rehabilitation of foot and ankle injuries and to provide support, stability, and protection to the foot and ankle during the healing process in cases of fractures, sprains, post- surgery, or severe foot or ankle injuries.

379

Ostomy adhesive

Adhesive to be placed around stoma to attach 2 piece ostomy collection device.

380

Otoscope cover

A disposable ear specula is a plastic cover which fits onto an otoscope to form a physical barrier protecting patients against cross contamination.

381

Oxygen mask respiration indicator

Designed to be attached to the exhalation vent hole on the exterior of a standard oxygen face mask and provide visual indication of patient respiration.

382

Packer, gauze

To be used in dentistry and dental surgery for introducing and packing gauze or dressings into cavities.

383

Panniculus skin-adhesive retractor, reusable

This retractor is intended to be used on intact skin for positioning redundant tissue (i.e., post c-section, post laparotomy) away from the lower abdominal incision/wound.

384

Parallel bar exerciser

Intended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk.

385

Patient audiovisual communication system

It is intended for use by trained personnel in functional, interventional and clinical MRI environments to facilitate audio communications during a scanning session.

386

Patient enclosure system

A freestanding, framed, tent-like structure designed to be constructed on-site to function as a temporary enclosure for safe playing, resting or sleeping, typically for a patient with autism, epilepsy, challenging behaviours and/or learning difficulties. It has a soft fabric/plastic interior with padded regions to prevent injury, and a limiting and low-stimulation environment.

387

Patient gown, non-sterile

Intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor’s office).

388

Patient holder

The device is used to support patient’s trunk and or lower limbs into a more symmetrical position. The intended patient group are those with disabilities who require assistance to maintain an optimal position, therefore preventing secondary complications such as joint contractures, pressure areas and pain.

389

Patient isolation tent canopy

A non-sterile covering designed to be used with a frame to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g. diphtheria, meningococcus) whilst the patient is being treated.

390

Patient lift

Intended as an assistive device to lift and transfer a patient with limited mobility from one place to another.

391

Patient transfer board

Intended to reduce the friction and difficulty during the task of moving or transferring a patient from a surface to another e.g. Bed to stretcher and reduce risks associated with manual handling by the staff

392

Pedal exerciser

Intended for exercise therapy for upper and/or lower body.

393

Pediatric gait trainers

Intended to assist and train children unable to walk or stand independently to enhance movement and independent ambulation

394

Pelvic floor exercise biofeedback device

It is intended for encouraging regular pelvic floor exercises; strengthening of the pelvic floor muscles; rehabilitation and training of weak pelvic floor muscle; treatment of stress, urge and mixed urinary incontinence in women; improving sexual pleasure or function in women with existing pelvic floor dysfunction; improving pelvic floor function in the post-partum period; improving mild to moderate prolapse symptoms

395

Pelvic traction kit (with/without weights)

Intended to apply uniform and controlled traction to the lumbar, sacral, and thoracic areas of the vertebral column.

396

Pen torch

Intended to assist with examinations by illuminating regions of the eye mount or ear.

397

Periodontic hoe

A hand-held manual dental instrument with a small blade at an acute angle (e.g., 90 degrees) to its stem intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned.

398

Philadelphia collar (cervical)

Intended to be used in cervical fracture to support neck bones and ligaments by restricting the movement of the neck muscles

399

Phoropter arm

Used to mount the phoroptor during an ophthalmic examination; typically to mount the phoroptor to determine a patient’s prescription for glasses.

400

Phototherapy eye protector, single- use

Intended to cover and protect the eyes of a patient from potentially harmful rays [e.g., ultraviolet (UV)] to which their body is intentionally exposed during light therapy treatment.

401

Phototherapy infant blanket

A piece of fabric, made from ultraviolet (UV) light transmittable material, intended to be used to wrap a newborn/infant during UV phototherapy for the treatment of neonatal jaundice (neonatal hyperbilirubinemia) to enable therapeutic light to pass through to the patient while simultaneously providing comfort. It does not include a light source.

402

Physical restraint

Intended to secure patient to chair, wheelchair, bed etc. to prevent self-harm or injuries to the health care professional handling the patient

403

Physical therapy table, line powered

Intended to facilitate functional training of patients/subjects with loss of lower extremity, upper extremity or core functionality, caused by conditions of orthopedic, musculoskeletal, neurological, or other origin by providing muscular load in combination with visual feedback.

404

Physio Motion Therapy BTL-CP Motion

Intended to be used during the first phase of rehabilitation following lower limb joint surgeries or traumas.

405

Picture archiving and communication system

A device intended for the recording, viewing, presentation and storage of digital still frames and video sequences for use with a microsurgical operating system.

406

Pill crusher/splitter

A hand-held device used for crushing or splitting medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole.

407

Pinwheel

Intended for testing pain sensation

408

Plaster instruments/plaster saw

A instrument used to cut or shave or put plaster.

409

Plaster of Paris bandage

It is intended for support of fractured body part.

410

Plaster spreader

used to separate and spread hardened plaster

411

Pneumatic external knee joint

Intended to replace knee joint in persons with lower limb amputation and connecting to above knee prosthesis

412

Pneumatic stander

Standing aid chair for Disabled Person

413

Pneumatic tourniquet and its attachment

Used for stopping flow of blood through artery by compression.

414

Pneumatic walker

To provide pneumatic compression and support to the ankle joint.

415

Portable system mount

Intended to be fixed vertically within a clinical setting to enable the easy and secure mounting of a portable medical device.

416

Positioning aid system

A mattress system specifically designed for the disabled person allowing various positions to be maintained with the aid of positioning aids. designed to allow air flow to reduce sweating/heat and therefore the possibility of spasm.

417

Postpartum maternity belt

It is intended to help reduce swelling, provide support to the lower back and abdominal muscles, and promote healing after delivery.

418

Postsurgical head/neck garment

It is a wearable contoured cranial cover intended for the restoration or augmentation of cosmetic appearance in patients with bony defects of the cranium.

419

Postsurgical transparent eye shield, vented

A device designed to be worn over the eye to protect the eye while allowing the wearer to see, typically following ophthalmic surgery. It is designed as a transparent self-adhesive dome which includes vent holes to allow air to circulate around the eye. This is a single-use device.

420

Power wheelchair

Intended to aid in mobility of individuals with physical disability, lack of senses in lower extremities and having difficulty in walking.

421

Power-assisted foot/hand-propelled tricycle

Power assisted foot/hand propelled tricycle designed specifically for people with disabilities

422

Prescription spectacles

An ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user’s eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye’s diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

423

Professional examination gown, non- sterile

Intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids.

424

Prophylaxis cup/ Dental polishing cup

This is a device that is intended to be used as a polishing cup to apply polishing agents during dental prophylaxis (cleaning). The device is held in a dental handpiece.

425

Proprioceptive nest

Intended to give physical support to the preterm newborn. It is designed to provide preterm babies with age-appropriate proprioceptive stimulation as well as comfort, a sense of security, and tactile stimulation.

426

Prosthetic external arm

Intended to be used as an external prosthesis for upper limb distal to shoulder joint by patients with upper limb loss or deficiency.

427

Prosthetic external foot (Winged Foot)

Intended for persons with a lower-limb amputation to restore lost mobility

428

Prosthetic foot, pediatric

Intended for children with a lower-limb amputation to restore lost mobility

429

Protective garment for Incontinence

Intended to protect an incontinent patient’s garment from the patient’s excreta.

430

Psychophysiological biofeedback system

Intended to improve certain medical conditions through user interaction, including anxiety, depression, pain, loneliness, mood and/or motivation; and for symptoms such as agitation, aggression, walking about found in some mental health disorders and/or neurocognitive disorders such as dementia.

431

Pulmonary equipment filter

Intended to prevent biological contaminants from entering pulmonary function testing equipment to help protect the patient and equipment during lung function tests.

432

Pulmonary exerciser

The device is a handheld device that is intended to improve expiratory/exhalation and inspiratory/inhalation muscle strength for the enhancement of breathing, coughing, swallow, voice and fitness.

433

Radiographic ECG/respirator synchronizer/X-ray synchronizer

A radiographic ECG/respirator synchronizer/X-ray synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.

434

Radiographic film illuminator/X-ray LED view panel

A radiographic film illuminator is a device containing a visible light source (e.g., LED) covered with a translucent front that is intended to be used to view medical radiographs.

435

Radiographic film marking system/radiographic film marker

A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

436

Radiographic film processor, automatic

It transports dental x-ray film from one solution to the next in the film developing process without any manual labour except the insertion of the film/cassette.

437

Radiographic film, non-screen

Intended to record images during diagnostic radiologic procedures.

438

Radiographic grid/X-ray grid/Anti- scatter grid

A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor

439

Radiographic head holder

Intended to position the patient’s head during a radiographic procedure.

440

Radiographic/X-ray cassette holder (wall-mounted/ceiling mounted/floor standing)

Intended to be used as a support to hold and position radiographic cassettes for a radiographic exposure for medical use.

441

Radiological breast positioning device, wearable

The device is indicated to aid in supporting adolescent and adult patients undergoing radiation therapy including electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning.

442

Radionuclide test pattern phantom

A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque material sealed in a solid pattern intended to serve as a test for a performance characteristic of a imaging device.

443

Reciprocating walking frame

Intended to be used a walking aid by people with physical disabilities or poor balance

444

Reclining wheelchair

A walking aid that reclines enabling the person to change positions from sitting to lying down.

445

Recording paper

This device is specially produced paper intended to be used for recording the output of devices measuring physiologic parameters, e.g. electrocardiogram (ECG), electroencephalogram (EEG) or ultrasound imaging or for recording fetal images.

446

Rectal dilator

Intended to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function. This is a single-patient use device and is intended for transient use.

447

Rescue blanket

Intended to keep a person warm and/or to prevent the further loss of body heat in emergency/rescue situations.

448

Retractor holder

Intended for mounting of surgical retractors.

449

Reverse-image mirror, dental

A device designed to be placed at the back of the teeth while taking image for dental examination purposes.

450

Rib belt

Intended for providing support and compression to the ribcage and relief from rib pain and discomfort, especially after injuries or surgeries, supporting breathing and coughing during recovery, and preventing rib injuries in certain sports or physically demanding professions.

451

Rod cutter/reducer

Intended to be used to reduce or seat an implantable rod into the saddle of the implant.

452

Rollator

Intended as a walking aid for balance and stability in individuals with limited mobility.

453

Rongeur, dental

To be used in dental surgery to remove hard or tough body tissues such as cartilage or bone, by applying a biting/cutting action. This is a reusable device.

454

Rotating vestibular chair

A tilting and rotating chair intended to be used in clinical procedures for testing vestibular-ocular disorders.

455

Scalpel blade remover, non sterile

Intended to assist the removal of used/blunt blades from a scalpel handle during a surgical procedure

456

Scoop stretcher

Intended to transfer a trauma patient and reduce the chance of undesirable movement of injured areas.

457

Shaped ankle wedge prosthesis, adult

Intended to be used as external artificial joint that is designed to replace the ankle joint in adults

458

Shaped ankle wedge prosthesis, pediatric

Intended to be used as external artificial joint that is designed to replace the ankle joint in children

459

Shield, resuscitation

To minimise tissue contact and exchange of fluids between parties during mouth to mouth resuscitation.

460

Shoulder wheel

It is a device that allows patients to perform resistance exercises to improve range of motion and relieve pain (intended for hospital use)

461

Single use binocular indirect lenses

Intended for visualization of the human retina (fundus) using a binocular indirect ophthalmoscope.

462

Single-chamber venous compression system garment, reprocessed

Deep Vein Thrombosis (DVT) Garments are part of an external compression system, in which intermittent compression is provided using a pump/controller and limb garment. When coupled with an appropriate inflation system, garments are intended for use in preventing deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency.

463

Skin abrasion device/file

Intended for debridement of thickened nails and callus.

464

Skin adhesive protective material

Intended to protect healthy skin from friction during removal of tapes and films. It provides a thin protective layer on the skin and helps tape and film adhesion.

465

Skin marker guide

A non-sterile device intended to be used as a guide to create markings on the skin surface with a drawing skin marker, typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application.

466

Skin marking transfer paper

A non-sterile, non-invasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure. This is a single-use device.

467

Skin pressure protectors

Intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient’s developing decubitus ulcers (bedsores)

468

Skin-cover sealant/Synthetic polymer liquid barrier cream

This is a non-cytotoxic cyanoacrylate based liquid skin barrier film for the skin to form a transparent flexible film to prevent skin irritation caused by moisture eg. urine, friction from bedding and by adhesive products.

469

Slit Lamp

Intended to be used as a specialized magnifying microscope to examine the structures of the eye (including the cornea, iris, vitreous, and retina).

470

Snoring sensor

Intended for use in the detection of snoring, muscle movement, respiratory effort and/or airflow.

471

Soft dental reliner

Intended to be used as a tissue conditioner and a reliner for short term use for removable dentures. It may be intended for professional and/or home use.

472

Soft rehabilitation glove

Intended for rehabilitation training of patients with finger joint dysfunction.

473

Solid-ankle-cushion-heel (SACH) foot

Intended for persons with a lower-limb amputation to restore lost mobility

474

Spatula

An instrument, usually made of stainless steel, which is used to spread a material on a surface, to fill material into a cavity, manipulate tissue or to remove a material from a surface. This is a reusable device.

475

Spine orthosis

An externally-applied wearable appliance intended to support and correct deformities of the spine. It may be one of numerous different designs and is typically made of synthetic and textile materials. This is a single-patient reusable device.

476

Stair chair

Supports and transports a patient occupant in a seated position up or down a set of stairs.

477

Standing wheelchair

Intended as a walking aid that allows users to raise themselves in upright position using upper limbs

478

Sterilization/disinfection containers

Intended to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s).

479

Sterilizer/disinfector rack

A non-sterile rack intended to hold medical devices in a steriliser or chemical washer/disinfector during the sterilisation or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their storage. This is a reusable device.

480

Sternal binder

Intended to stabilize and support the sternum after sternotomies

481

Stress exercise trolley

This treadmill is intended to be used for cardiac stress testing.

482

Suction system filter, non sterile

A filter used with a suction system to separate tissue from the fluid waste collected from a medical procedure.

483

Surgical camera and accessories

Intended to be used to record operative procedures.

484

Surgical camera holder

Intended to hold and position a camera, or camera system and/or other devices during surgical procedures.

485

Surgical cap, non-sterile

Intended to protect face of patient & the operating room personnel from the transfer of micro- organisms, body fluids & particulate material.

486

Surgical eye pressure shield

A non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare professionals, equipment, or due to the orientation of the patient).

487

Surgical helmet, non-sterile

Intended to protect healthcare workers from contaminants & debris on head.

488

Surgical implant handling forceps

A hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. This is a reusable device intended to be sterilized prior to use.

489

Surgical instrument assist arm system

The device assists in maintaining spatial positioning of instruments during surgical procedures

490

Surgical instrument holder, reusable

device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s)

491

Surgical instrument rack

Intended for the safe storage and counting of used sharps during and prior to the the end of a surgical procedure. The used sharps are held in place by foam, magnet or other mechanisms and the device can be closed securely for safe sharps disposal.

492

Surgical knee cover

Reusable surgical cover used as a protective cover to protect the patella during knee surgery.

493

Surgical lamp (ophthalmic)

Intended to serve as a cold light source for illumination of the intraocular posterior segment in optical surgery in case of vitrectomies.

494

Surgical lens (camera accessory)

A device designed to be used with a camera, or a camera system being used during medical procedures.

495

Surgical light/illumination system/OT lights

Intended to providing optimal light and colour rendering to aid surgery.

496

Surgical material compression device

A reusable manual instrument intended to flatten material, such as tissue, for use in a surgical procedure (e.g., tympanoplasty) after it has been flattened.

497

Surgical microscope and accessories

Intended for use during surgery to provide a magnified view of the surgical field.

498

Surgical sleeve cover, non-sterile

It is a forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during procedures to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate materials between the patient and staff.

499

Surgical torque wrench adaptor

This is a hand held component of a surgical wrench that is intended to connect to the main body of the wrench to a variety of distal end pieces (bits) and assist with the use of a torque wench in the mouth during a dental procedure.

500

Surgical trays

Intended to provide a suitable platform for general containment of many medical/surgical instruments and related items during a clinical procedure.

501

Surgical video camera

A video camera used to generate video images of surgical procedures, which are fed to a monitor screen for local or external viewing.

502

Tearable adhesive plaster

It is intended to secure dressings and for strapping on intact skin.

503

Tearable adhesive tape

It is intended to secure dressings and for strapping on intact skin.

504

Tester, colour discrimination

Devices for colour vision testing

505

Testicular temperature regulation underpants

This is a garment that is body worn that is intended to be placed around the pelvic region in the same manner as conventional male underwear that is designed to keep the testicles cool for increased spermatogenesis, as part of an fertility treatment, through ventilation features (e.g., breathable mesh) that prevent excessive insulation of the testes.

506

Therapeutic medical binder, general purpose

Intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place like abdominal, breast and perineal binder.

507

Therapeutic scrotal support

Intended for medical purposes to support the scrotum (the sac that contains the testicles)

508

Thermographic camera

It is a thermal based imaging device, intended for viewing and digitally storing thermal patterns generated by the human body in a clinic, hospital, acute care setting, surgery, healthcare practitioner facility or in any environment where healthcare is provided by a qualified healthcare professional.

509

Thermoplastic mask for immobilization

Intended to immobilize the patient to deliver the correct Radiation dose

510

Thumb spica splint

Intended to minimize movement and provide support and comfort by stabilizing an injury of the thumb

511

Tongue scraper

A device used to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It may be single use or reusable and is an OTC device.

512

Tongue-retaining sleep-disordered breathing orthosis

A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by retention of the tongue, frequently keeping the tongue in a forward position during sleep.

513

Tracheostoma shower shield

A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering.

514

Tracheostomy tube holder

Intended to secure a patient’s tracheostomy tube for use on pediatric (neonates, infants and children) patients.

515

Tracheostomy tube neck holder, single-use

To secure a tracheostomy tube by fastening around the neck of the patient. Composed of cotton/velour and a velcro fastening.

516

Training aid for communication and speaking

Designed for the assessment of disordered voice and speech, and voice and speech therapy.

517

Training aid for perceptual sense and co-ordination

This device is an exercise system that promotes therapeutic exercises through use of one or more sensorized movement controllers.

This device is indicated for use by patients with neurological or other movement impairment, typically from stroke, who are undergoing rehabilitation to facilitate muscle re-education, increased range of motion, or increased coordination.

518

Transcutaneous electrical stimulation electrode adhesive pad

Reusable gel pads that allow electrodes to adhere gently to the skin.

519

Trial frame

A device used in ophthalmic work for holding trial lenses in front of the eyes during the sight-testing procedure.

520

Truncal orthosis

Intended to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body.

521

Ulnar/brachial nerve protector

It is use to provide cushioning, support and protection to elbow and arms during prolonged surgeries.

522

Ultrasonic coupling gel

A coupling medium for ultrasound transmissions.

523

Ultrasonic safety goggle

Intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure.

524

Ultrasonic scanner calibrator

It is a block of material with known properties intended to be used to calibrate ultrasonic scanning devices

525

Ultrasound imaging phantom, test object

Intended to provide a standard of reference for routine and periodic verification of ultrasound doppler imaging equipment used for the identification of disease and pathologies.

526

Ultrasound imaging system table, non-powered

A non-powered patient table designed to support and position a patient specifically for ultrasound imaging procedures.

527

Ultrasound imaging system table, powered

An electrically-powered patient table designed to support and position a patient specifically for ultrasound imaging procedures.

528

Ultrasound imaging system workstation

A freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is typically considered to be a component to a picture archiving and communication system (PACS) and does not contain the controls for the direct operation of the diagnostic imaging system.

529

Ultrasound imaging transducer positioning unit

A unit used to position an ultrasound system imaging transducer that is inserted into the body through an endoscope. This device is an accessory to a diagnostic ultrasound imaging system and it transmits electrical signals that, after processing, will display the position of a the transducer on a monitor.

530

Umbilical cord clamp

Used for clamping the umbilical cord after birth.

531

Upper limbs gravity-compensating rehabilitation system

Intended to increase muscle strength, motion in different joints and improve motor function in patients who have lost their function or have restricted function in their upper extremities.

532

Urinary dilator

Intended to dilate the urinary duct

533

Urine drainage extension tubing

A conduit for urine collection, via a pouch and tubing, into a gravity drainage collection bottle or bag.

534

Urological operating table top

A component of a modular operating table designed as a detachable table top to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract.

535

Urological operating table, hydraulic/Transurethral resection table

A mobile table powered by manually-operated hydraulic mechanisms designed to support a patient during urological examination and surgical procedures, including cystoscopic procedures and both transurethral and open surgery of the urinary tract.

536

Vacuum cushion

Intended for positioning and re-positioning patients’ head & neck, thorax, hip and full body during radiation therapy and other diseases treatment.

537

Vacuum splint

Intended to immobilize and protect injured limbs so that the patient can be transported safely and easily in emergency conditions.

538

Vaginal applicator, reusable

Intended to apply medication to the vagina.

539

Vaginal applicator, single use

A single use device intended to apply medication to the vagina

540

Vaginal exerciser/Pelvic floor muscle exerciser

Designed to provide Kegel exercises to strengthen and tone the pelvic floor muscle, which in turn improves conditions such as female incontinence, sexual dysfunction, prolapse, etc.

541

Vaginal illuminator

A device used to illuminate the vagina during a gynaecological examination or procedure.

542

Vice grip

Intended to hold pliers during surgical procedures.

543

Video indirect ophthalmoscope

Intended as an illumination system to direct appropriately focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye and record the images and videos of the patient.

544

Video laryngoscope adaptor

Intended to serve as a connection between the laryngoscope and the display/monitoring device during intubation

545

Vision testing/training flipper

A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders.

546

Vision training software

A patient-interactive software package intended to use visual images (e.g., Gabor patch) to help improve vision based on noninvasive perceptual learning therapy (neuro-vision therapy), typically in patients with amblyopia, or who use corrective eyewear, or following ophthalmic surgery.

547

Visual field plotter

Device for visual field examination

548

Vitrectomy lenses

Intended to facilitate the visualization of the retina during Vitrectomy surgery.

549

Warming chamber

A chamber and accessories designed to warm various items prior to use, e.g. bags of irrigation or intravenous solutions, blankets, or clothing for operating theatre personnel

550

Washers for body waste receptacles

Intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan.

551

Weight activated knee joint external prosthesis

Intended as an artificial knee with a braking mechanism that prevents the knee from bending as long as the user has weight on the prosthesis

552

Weight-bearing protector for flat panel x-ray detector/film cassette

The device is a protector for a digital X-ray flat panel detector

553

Wheelchair

Intended to be used by physically disabled individuals and old age patients with limited mobility

554

Wheelchair accessory, power assisted conversion kit

A device that can only fulfil its purpose when used together with and to enhance the function of a wheelchair. It will provide the occupant/assistant with a powered driving assistance.

555

Wire tensioner

Intended to be used during orthopaedic surgery to apply an appropriate tension to a wire that is being implanted, usually as part of a system to provide corrective surgery to the spine. This is a reusable device.

556

Woven gauze pad, non-sterile

A non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to cover/clean superficial wounds or abrasions and absorb their exudates, absorb body- surface exudates, or to apply topical medications.

557

Woven gauze roll, non-sterile

A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression.

558

Woven gauze roll/sheet

A device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary superficial wound dressing, dressing retention, and injury padding and compression.

559

Wrist splint

Intended to temporarily render the wrist immovable as therapy for non-displaced fractures sprains & muscle injuries of the wrist.

560

Wrist/hand/finger flexion orthosis, manual

An externally applied orthopedic appliance intended to assist in the flexion of the wrist, hand, and fingers

561

Wrist/hand/finger stable-position orthosis

An externally applied orthopaedic appliance or apparatus designed to maintain both the transverse and longitudinal arches of the hand, and to hold the thumb in a functional position. This is a reusable device

562

Wrist/hand/metacarpophalangeal joint extension orthosis

Device is designed to assist in the extension of the wrist, hand, and metacarpophalangeal joints (MP joints or knuckles)

563

X- ray marker for strut

Intended to be used in Six axis correction apparatus with software.

564

X-ray film cover

A small envelope cover used to hold and protect x- ray films that goes into a patient’s mouth momentarily when taking an x-ray and then processed.

565

X-ray film magnifying glass

A convex lens used for magnifying the details of a viewed radiograph (x-ray) and shade against strong interfering light. It can be hand-held or mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.

566

X-ray film processing chemical, automatic

A chemical, e.g., a fixer or developer, which is necessary for automatic processing of x-ray film or other radiographic films used in, e.g., computed tomography (CT), magnetic resonance (MR), ultrasound or nuclear medicine.

567

X-ray film processing chemical, manual

A chemical, e.g., a fixer or developer, used in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications.

568

X-Ray hanger

Intended to position and hold the radiograph during X ray film development, eliminate streaking and maintain alignment.

569

Y-Connector (accessory to perfusion sets)

Intended to position and hold the radiograph during X ray film development, eliminate streaking and maintain alignment.

570

Acoustic chamber for audiometric testing

Intended for use in conducting diagnostic hearing evaluations, while eliminating sound reflections and providing isolation from outside sounds.

571

Aerosol delivery tubing

A flexible tube used in conjunction with an oxygen mask, endotracheal (ET) tube, humidifier, or nebulizer, intended for the delivery of aerosolized humidification, typically oxygen enriched.

572

Amsler grid

Intended to rapidly detect central and paracentral irregularities in the visual field.

573

Anaesthesia catheter Luer connector

Intended to create a mechanical union between an anaesthesia catheter and an external device

574

Anaesthesia depth simulator

intended to simulate the electroencephalography (EEG) signals of an unconscious patient

575

Anaesthesia mask stabilizer

A device intended to secure an anaesthesia mask on the face of a patient typically by providing anchorage for the fixation of the mask’s headstrap.

576

Anaesthesia system leakage tester

A device intended to test an anaesthesia system for leakage.

577

Anaesthesia warmer

A device intended to warm the anaesthetic solutions prior to it being administered to a patient for anaesthesia.

578

Anaesthetic gas scavenging terminal unit

A device intended to function as an outlet assembly to which the operator can connect/disconnect an anaesthetic gas scavenging system (AGSS).

579

Analytical non- scalp cutaneous lead

Intended to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance].

580

Ankle/foot orthosis

A prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance.

581

Ankle/foot orthosis

A prefabricated externally applied and wearable appliance or apparatus intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds.

582

Anomaloscope

Intended to test a patient for abnormal red/green colour vision by differentiating the red/green colour vision defects.

583

Antimicrobial postsurgical brassiere

Intended to support and/or contour the breast(s) or hold a dressing in place after surgical intervention (e.g. thoracic surgery, mastectomy, lumpectomy). May be used to prevent the formation of oedema and to support venous return and lymphatic drainage.

584

Antimicrobial postsurgical female underpants

It is intended for use during medical treatment (e.g., chemotherapy) or be used to protect the skin following treatment with a medication (e.g. ointment, cream).

585

Arm sling

Intended to immobilize the arm, by means of a fabric band suspended from around the neck.

586

Artificial airway stylet

A device intended for insertion within the lumen of an artificial airway tube to stiffen and/or maintain the shape of the tube to facilitate intubation.

587

Assistive ergonomic chair mobility base

Intended for use as a support to an assistive ergonomic chair used by a healthcare provider/carer to provide mobility for a disabled (often paediatric) patient.

588

Atomizer

A device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe.

589

Back Support/Brace

Intended to prevent unnecessary movements and pain that may further damage the back and to help in alignment of spine and strengthening of back muscles.

590

Bagolini lens

Intended to determine harmonious/anomalous retinal correspondence.

591

Balance Board

Intended to train patient with difficulties in balance (proprioreception) ( e.g. a paraplegic or a stroke patient)

592

Bar dental precision attachment

It connects removable partial dentures to fixed bridgework under a male/female locking mechanism.

593

Bed traction frame

Intended to provide overhead support framing for hospital beds to assist in the treatment and movement of bed patients

594

Bedrail pad

Intended to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves.

595

Birthing bath

Intended to be filled with heated water for use before and/or during child birth and to provide a comfortable environment for the expecting mother prior to birth.

596

Birthing bed/table, powered

Intended to be used as a support surface during labor and delivery.

597

Bite registration rim wax

A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims).

598

Bite relief pad

Intended to help relieve pain or discomfort after orthodontic treatment by placement between the upper and lower sets of teeth and bitten down on.

599

Body arch traction table

Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch

600

Breast binder

A non-sterile device intended to be applied to the breast or breasts for soft tissue support or securing a dressing in place after surgical procedures.

601

Breathing circuit condenser

Intended to be integrated within the expiratory limb of a breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate machine-compatible temperature.

602

Breathing circuit dryer

A device that is used for the purpose of drying breathing circuit equipment that have been washed in order to prevent bacteria growth and deterioration.

603

Breathing mouthpiece

A device intended to be inserted into a patient’s mouth to facilitate access to the respiratory system.

604

Canalith repositioning procedure chair, manual

A device intended to be occupied by a patient and manually operated by a healthcare professional to facilitate therapeutic physical manoeuvres of the patient’s head and trunk (accelerations and decelerations in a multiaxial plan) to treat balance disorders [e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient.

605

Capnography oxygen mask

A device intended to be placed over the nose and mouth to deliver oxygen (O2) to a patient’s airway and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status.

606

Cardiopulmonary resuscitation mask

A flexible, form-shaped device that is placed over a patient’s mouth to administer “mouth-to-mask” exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR).

607

Cervical cytology scraper, reusable

Intended to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer.

608

Cervical spine collar

Intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident).

609

Cervicothoracic spine orthosis

Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine.

610

Cervicothoracolumbosacral spine orthosis

Intended to encompass the cervicothoracolumbosacral spine region of the neck and trunk.

611

Chemotherapy spill clean-up kit

Intended to safely clean and dispose of Chemotherapy drug spills.

612

Circulating-fluid thermal therapy system

Designed to provide extended cold therapy to assist in a variety of applications as directed by a medical professional. It is designed not to be applied directly to the skin and is to be used as part of recovery from surgery either in the hospital setting or at home.

613

Cold compression therapy cervical spine collar

Intended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).

614

Cold/cool therapy gel

Intended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.

615

Colour discrimination tester

Intended to test a person’s ability to differentiate between colours.

616

Colour-discrimination eye chart

Intended for testing colour vision.

617

Congenital hip dislocation abduction splint

Intended to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).

618

Contact lens inserter/remover

Intended to insert and remove contact lenses from the eye.

619

Core-body mechanical weight exerciser

Intended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation.

620

Crutches

Intended to help transfer of load from the legs to the upper body of people who cannot use their legs to fully support the weight of their body due to temporary or permanent disabilities.

621

Cytotoxic waste receptacle

Intended to safely deposit, collect and store cytotoxic materials (e.g., chemotherapy/antineoplastic drugs).

622

Dappen dish, reusable

Intended to hold and mix dental materials.

623

Dappen dish, single-use

Used to hold and knead dental materials.

624

Denis Brown splint

Intended to immobilize the foot, particularly on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

625

Dental cotton roll

It is intended as an absorbent, hard-packed cylinder (a roll) that is used as a saliva absorber from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure.

626

Dental impression material

Intended to take an oral impression.

627

Dental impression material kit, reusable

A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s).

628

Dental impression material kit, single-use

A collection of non-sterile devices designed to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s).

629

Dental impression material mixer

An electric device used to mix impression materials immediately before use at the chair side

630

Dental impression tray material

A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance.

631

Dental impression tray, reusable

A impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient’s teeth to reproduce the structure of a patient’s teeth.

632

Dental impression tray, single-use

A impression tray is a metal or plastic device intended to hold impression material, to make an impression of a patient’s teeth to reproduce the structure of a patient’s teeth.

633

Dental material mixing surface, reusable

Intended to be used as a surface to mix dental materials.

634

Dental material mixing surface, single-use

Intended to be used as a surface to knead or mix dental material (impression material, cement, etc).

635

Dental spatula, reusable

Used for kneading or mixing dental material (impression material, cement, etc).

636

Dermatome skin approximation tape

Intended for attachment onto a skin graft knife to collect a skin graft tissue.

637

Diagnostic condensing lens

Intended for use in binocular indirect ophthalmoscopy to focus reflected light from the fundus of the eye.

638

Diagnostic x-ray tube mount

Intended to support and to position the diagnostic x- ray tube housing assembly for a medical radiographic procedure.

639

Diaphragm wearable urinal

A non-sterile urine drainage device designed for men with incontinence consisting of a front piece with a scrotal support and a leak-proof, flexible diaphragm through which the penis passes into a closed coneshaped tube connected to a leg bag into which the urine is collected.

640

Draping incontinence liner

A non-sterile padded sheet intended to cover a device/piece of furniture (e.g., wheelchair, bed, sofa) occupied by an incontinent person to catch and retain urine.

641

Drip wearable urinal

A non-sterile urine drainage device designed for men to contain a moderate leakage consisting of a front piece with an integrated tubular sheath that fits fully over the penis and into which dribbling urine is collected.

642

Dry powder inhaler

Intended to administer powdered medicine through the mouth and into the bronchial airways.

643

Dry salt therapy device

Intended to provide an inhalation of prefilled salt particles through the mouth and into the bronchial airways to induce natural self-cleansing mechanisms that flush away the impurities from the surface of cells and mechanically clean the airways.

644

Ear bowl

Intended to fit the curvature of the head and sit closely under the ear lobe to enable ear treatments.

645

Ear canal impression tray

Intended to hold and confine the impression material in opposition to the surfaces to be recorded, and to control the impression material while it sets to form the impression of the ear canal.

646

Ear canal light

Intended to illuminate the ear canal.

647

Ear microsystem needle

Intended to apply continuous pressure to stimulate meridian points during auriculotherapy

648

Ear wick

Intended to minimize bleeding during ear surgery.

649

Elbow orthosis

A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow.

650

Electronic occlusion spectacles

Intended to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes.

651

Endotracheal tube introducer

Intended to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation

652

ENT chair, electric

Intended to support a patient in a seated position, electrically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery.

653

ENT chair, mechanical

Intended to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery.

654

ENT surgical microscope

Intended to magnify minute structures (e.g., nerves, vessels) in the performance of ear, nose, and/or throat (ENT) surgery requiring high magnification and adjustable focusing.

655

ENT transilluminator

Intended to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination

656

Euthyscope

Intended to project a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia.

657

Exothermic heat therapy pack

Intended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain.

658

External asembled lower limb prosthesis

Intended for use as an preassembled external artificial limb for the lower extremity.

659

External limb prosthesis socket liner

Intended for use as an interface that goes between a person’s skin and his or her prosthetic to protect the wearer’s skin while enhancing comfort and maintaining a more consistent fit.

660

External nasal splint

Intended for external use for immobilization of parts of the nose.

661

Eye cup

Intended to fit around the eye socket and placed over the eye to allow washing of the affected eye.

662

Eye irrigation shield

Intended for use with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye.

663

Eye spud

Intended to remove a foreign body/object embedded in or adhering to the surface of the eye globe.

664

Eyelid clamp

Intended to automatically grasp and hold the eyelid during an ophthalmic surgical intervention.

665

Eyelid weight, external

Intended to be applied to the outside of the upper eyelid to “lidload” the eyelid to restore upper eyelid muscle function.

666

Face shield

Intended to protect the wearer’s entire face (or part of it) from hazards such as chemical splashes (in laboratories or in industry), or potentially infectious materials (in medical and laboratory environments).

667

Felt tangent screen

Intended for assessing the extent of the patient’s peripheral visual field by mapping the visual response to a test object moved from the periphery towards the centre of the screen.

668

Female wearable urinal, reusable

A non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag.

669

Finger/thumb prosthesis

Intended as an artificial substitute for a missing finger or thumb

670

Flotation therapy bed, adult

A mains electricity (AC-powered) bed designed to minimize pressure points on a patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort.

671

Flotation therapy bed, neonatal

A fixed (non-adjustable) device designed with a mattress or cushions containing air, water, gel, or other appropriate material used for the continuous care of newborns, and sick and/or premature babies.

672

Fornixscope

Intended to provide indirect access and viewing of the upper conjunctival fornix and inner surface of the eyelid as an alternative to eyelid eversion.

673

Fresnel lens

Intended to be applied to the back of spectacle lenses to focus light to a focal point to help manage various vision conditions.

674

Fresnel prism

Intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction.

675

General-purpose manually-operated operation table

A mobile, manually-operated hydraulic table designed to be adjusted to support a patient during many types of surgical interventions.

676

Gonadal radiation protector

Intended to attenuate unnecessary radiation exposure in diagnostic, medical or dental procedures, and shield the gonad of the patient and the operator.

677

Gravity enema set

Intended to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine.

678

Gynaecological bib

Intended to be worn by the patient during gynecological examinations and procedures.

679

Gynaecological operating table top

Intended to support a patient during gynaecological surgical procedures

680

Gynaecological surgical microscope

Intended to improve visualization of anatomical structures via

transmitted light during gynaecological surgery (e.g., on the fallopian tubes).

681

Haidinger brush imager

Intended to produce an image which facilitates visual function evaluation, particularly the macular integrity.

682

Hand/finger splint

Intended to immobilize an injured hand to protect from injuries to the digits, metacarpals, and wrist during the healing process.

683

Hand-held telescope

Intended to enlarge images for a visually impaired patient/person.

684

Hand-held urinal, female

Intended as a container/set to be directly urinated into by a female (typically bed-bound) patient for excretory purposes.

685

Hand-held urinal, male, reusable

Intended as a container to be directly urinated into by a male (typically bed-bound) patient for excretory purposes.

686

Heel stirrup

Intended to position and support the patient’s foot, lower leg and upper leg in a variety of surgical procedures including, but not limited to gynecology, urology, laparoscopy, general and robotic surgery.

687

Horizontal non-powered traction system

Intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae of patient by means of attached harnesses.

688

Hruby fundus lens

Intended for use in the examination of the vitreous body and the fundus of the eye under slit lamp illumination and magnification.

689

Hydrotherapy treadmill

Intended for use in partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to the treadmill walking exercise without increasing the impact and/or stress on the patient’s joints.

690

Ice bag

Intended to alleviate pain and/or promote healing in minor injuries of the body or for application around the neck or limbs.

691

Incentive spirometer

Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing.

692

Incontinence device suspender

A device used by a person with a disability to secure a body-worn incontinence device [e.g., a nappy (diaper) or a pad] in a stable and safe position

693

Incontinence penis clamp, reusable

Intended to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder.

694

Indirect binocular ophthalmoscope

An ophthalmic instrument designed to examine the interior of the eye allowing the examiner to clearly see a wide angle, stereoscopic impression of the details of the fundus (retina) and other structures.

695

Infant care table

Intended for use in nursing, e.g., washing or changing of nappies, of newborn babies.

696

Infant incubator warming hood

Intended to provide warmth to an incubator chamber by placement above the chamber.

697

Infant inguinal hernia truss

Intended to be worn over the groin to prevent protrusion of abdominal contents in an infant with an inguinal hernia.

698

Infant limb immobilizer, reusable

Intended to temporarily render parts of an infant’s body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions.

699

Infant limb immobilizer, single- use

Intended to temporarily render parts of an infant’s body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions.

700

Infant resuscitation table

It is a patient platform that can be used to facilitate neonatal transition at birth. It provides a stable platform for mother side resuscitation and stabilization practices.

701

Infant sleep positioner

Intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent back-sleeping position.

702

Infant-hammock bed mattress

Intended to be placed in a cot/crib/bassinet/bed/incubator and to cradle a young infant during sleep/rest, and can used for phototherapy, transportation and burns patients. Intended to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), pressure sores, and hyperthermia.

703

Infant-hammock bed mattress overlay

Intended to be placed on a cot/crib/bed mattress and to cradle a young infant during sleep/rest to help reduce the risk of infant injuries/disorders such as suffocation, flat head (plagiocephaly), sudden infant death syndrome (SIDS), and hyperthermia.

704

In-line arterial blood sampling set

A collection of devices designed to obtain an in-line arterial blood specimen while maintaining a closed system.

705

In-line backflow valve

A general-purpose device used in medical tubing or pipelines to prevent the backflow of gases or liquids.

706

Intestinal stoma shield/support belt, reusable

A non-sterile plate intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin.

707

Intubation teeth protector

A device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures.

708

Inversion table

Intended to support the body of a patient and provide traction for the back muscles and spine by allowing the patient manually invert their entire body in a supine position (feet up and head down), thereby assist in alleviating back pain.

709

Kinetic bed

Intended to enable continuous change of the patient’s lying position.

710

Laryngeal airway introducer

A device intended to aid insertion of a laryngeal airway into the pharyngeal cavity of a patient while reducing or eliminating the need for finger manipulation within the mouth.

711

Light beam patient position indicator

Intended to project a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam.

712

Liquid crystal vein locator

Intended to indicate the location of a vein by revealing variations in the surface temperature of the skin.

713

Maddox trial lens

Intended as a device that change the size, shape, and colour of an image to dissociate the eyes in the evaluation of eye muscle dysfunction.

714

Manual radionuclide applicator system

Intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy.

715

Massage table/couch

Intended for supporting body during therapeutic massages (not intended for general wellness purpose).

716

Medical gas terminal unit

A device that is a component of a medical gas pipeline system or a medical gas/vacuum pipeline system that has a gas-specific outlet connection for a single/mixture of gas to which the operator can connect and disconnect a

medica device.

717

Medical image storage device

Intended to provides electronic storage and retrieval functions for medical images.

718

Medical image storage device

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

719

Medicine chamber spacer

A device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient’s mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles.

720

Mirror-prism spectacles

Intended to enable the patient to see over the top of their head enabling them to look forward in the direction their head is pointing.

721

Mobile radiation protection barrier

Intended to protect the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures.

722

Motorized diagnostic imaging view box

Intended to retain, retrieve, and project light for direct observation of medical images taken using a variety of methods such as X‐ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film.

723

Nappy changing table, portable

Intended to support an infant, child or an adult during nappy (diaper) changing, or for a patient with a disability who is incontinent and requires regular changing of their nappies.

724

Nasal aspirator, electric

Intended for superficial use to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing.

725

Nasal dilator

Intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow.

726

Nasal septum straightening forceps

Intended to straighten the nasal septum through grasping and manipulation of the bone/cartilage of the septum during nasal reconstructive procedures.

727

Nasogastric tube holder, intranasal

The device is used with enteral feeding tubes to prevent inadvertent removal or displacement of the tubes for adult patients.

728

Newborn-infant bed

Intended as support surface to newborn babies.

729

Non-powered accelerator system table

Intended to adjust the patient’s posture and immobilize the patient for radiotherapy.

730

Non-powered neutron therapy table

Intended to adjust the patient’s posture and immobilize the patient for treatment that uses neutron rays.

731

Non-powered remote irradiation therapy table

Intended to adjust the patient’s posture and immobilize the patient for treatment that uses a remote radionuclide radiotherapy apparatus.

732

Non-powered X-rays radiation therapy table

Intended to adjust the patient’s posture and immobilize the patient for treatment using X-ray radiation therapy

733

Non-rebreathing oxygen face mask

A flexible, form-shaped device designed with valve to control rebreathing and contamination of gas, placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient’s airway for oxygen therapy.

734

Nose clip

It is a device used to help prevent air movement through

the nose. It is typically used during pulmonary function tests to ensure that airflow is focused through the mouthpiece for accurate measurement.

735