| 4-dot binocular vision test | | 4-dot binocular vision test | | Class I Devices |
| A heat reflective jacket designed to prevent hypothermia and shock | | A heat reflective jacket designed to prevent hypothermia and shock | | Class I
|
| A radiant heat reflective emergency bag to treat shock and hypothermia | | A radiant heat reflective emergency bag to treat shock and hypothermia | | Class I
|
| A1 | | Measuring and mixing devices for medicines | | Class I Devices |
| A1 | | Measuring Cups/Spoons/Droppers | | Class I Devices |
| A1 | | Medical measuring dosage spoons and oral dosage syringes | | Class I Devices |
| A1 | | Medical measuring dosage spoons and oral dosage syringes | | Class I Devices |
| A2 | | Inhalation Devices (E.G. Chamber Spacers) | | Class I Devices |
| A2 | | Inhalation Devices (E.G. Chamber Spacers) | | Class I Devices |
| A3 | | Sets - Solution/Irrigation (Gravity Only) | | Class I Devices |
| A3 | | Sets - Solution/Irrigation (Gravity Only) | | Class I Devices |
| A4 | | Syringes (Hypodermic/Oral/Irrigation) | | Class I Devices |
| A4 | | Syringes (Hypodermic/Oral/Irrigation) | | Class I Devices |
| A5 | | Dispensers (Cement, Etc.) And Accessories | | Class I Devices |
| A5 | | Dispensers (Cement, Etc.) And Accessories | | Class I Devices |
| A6 | | Sensitivity Testing Devices | | Class I Devices |
| A7 | | Non-Active Autoinjector Devices | | Class I Devices |
| A7 | | Non-Active Autoinjector Devices | | Class I Devices |
| A8 | | Non-Active Infusion Devices And Accessories | | Class I Devices |
| A8 | | Non-Active Infusion Devices And Accessories | | Class I Devices |
| Abdominal aorta endovascular stent-graft | | Abdominal aorta endovascular stent-graft | | Class III
|
| Abdominal binder, reusable | | Abdominal binder, reusable | |
|
| Abdominal binder, reusable | | Abdominal binder, reusable | | Class I
|
| Abdominal decompression chamber pump | | Abdominal decompression chamber pump | |
|
| Abdominal decompression chamber pump | | Abdominal decompression chamber pump | | Class IIb
|
| Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial | | Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial | | Class IIb
|
| Abdominal hernia truss, reusable | | Abdominal hernia truss, reusable | |
|
| Abdominal hernia truss, reusable | | Abdominal hernia truss, reusable | | Class I
|
| Abdominal paracentesis needle, single-use | | Abdominal paracentesis needle, single-use | | Class IIa
|
| Abdominal public health screening x-ray system | | Abdominal public health screening x-ray system | |
|
| Abdominal scissors | | Abdominal scissors | | Class I
|
| Abdominal/intestinal spatula | | Abdominal/intestinal spatula | | Class I
|
| Abrasive Skin Preparation Tabs | | Abrasive Skin Preparation Tabs | | Class I
|
| Absorbent stomal dressing | | Absorbent stomal dressing | | Class I
|
| Absorbent tipped applicator, non-sterile | | Absorbent tipped applicator, non-sterile | | Class I
|
| Absorbent tipped applicator, sterile | | Absorbent tipped applicator, sterile | | Class I Devices |
| Absorbent underpad, non-antimicrobial | | Absorbent underpad, non-antimicrobial | | Class I
|
| Absorbent wound compression pad | | Absorbent wound compression pad | |
|
| Absorbent wound compression pad | | Absorbent wound compression pad | | Class I
|
| Accessories For Implantable Devices (Non-Invasive) | | Accessories For Implantable Devices (Non-Invasive) | | Class I
|
| Accessory, bite block, for endoscope | | Accessory, bite block, for endoscope | | Class I Devices |
| Acetabular augmentation implant | | Acetabular augmentation implant | |
|
| Acetabular augmentation implant | | Acetabular augmentation implant | | Class IIb
|
| Acetabular orthopaedic reamer | | Acetabular orthopaedic reamer | |
|
| Acetabular orthopaedic reamer | | Acetabular orthopaedic reamer | | Class I
|
| Acetabular orthopaedic reamer | | Acetabular orthopaedic reamer | | Class IIa
|
| Acetabular shell | | Acetabular shell | |
|
| Acetabular shell | | Acetabular shell | | Class IIb
|
| Acetabular shell | | Acetabular shell | | Class III
|
| Acetabulum prosthesis hole plug | | Acetabulum prosthesis hole plug | |
|
| Acetabulum prosthesis hole plug | | Acetabulum prosthesis hole plug | | Class IIb
|
| Acetabulum prosthesis trial, prefabricated, reusable | | Acetabulum prosthesis trial, prefabricated, reusable | |
|
| Acetabulum prosthesis trial, prefabricated, reusable | | Acetabulum prosthesis trial, prefabricated, reusable | | Class I
|
| Acetabulum prosthesis trial, prefabricated, reusable | | Acetabulum prosthesis trial, prefabricated, reusable | | Class IIa
|
| Acetabulum prosthesis | | Acetabulum prosthesis | | Class IIb
|
| Acetabulum prosthesis | | Acetabulum prosthesis | | Class III
|
| Acoustic earmuffs | | Acoustic earmuffs | |
|
| Acoustic rhinometer | | Acoustic rhinometer | | Class IIa
|
| Acromioclavicular joint stabilization implant | | Acromioclavicular joint stabilization implant | | Class IIb
|
| Active Cables | | Active Cables | | Class I
|
| Active Medical Device Accessories (e.g. batteries, chargers, power supply units) | | Active Medical Device Accessories (e.g. batteries, chargers, power supply units) | | Class I
|
| Acupressure applicator, reusable | | Acupressure applicator, reusable | | Class I
|
| Acupressure Devices and Copper Bracelets | | Acupressure Devices and Copper Bracelets | | Class I
|
| Acupressure wristband | | Acupressure wristband | | Class I
|
| Acupuncture electrical stimulation system | | Acupuncture electrical stimulation system | |
|
| Acupuncture electrical stimulation system | | Acupuncture electrical stimulation system | | Class I
|
| Adenoid curette, reusable | | Adenoid curette, reusable | | Class I
|
| Adenoid punch forceps | | Adenoid punch forceps | | Class I
|
| Adhesive bandage | | Adhesive bandage | | Class I Devices |
| Adhesive bandage | | Adhesive bandage | |
|
| Adhesive bandage | | Adhesive bandage | | Class I
|
| Adhesive Plasters/Dressings/Tapes/Barrier Films | | Adhesive Plasters/Dressings/Tapes/Barrier Films | | Class I
|
| Adhesive Plate Cables, Footswitches | | Adhesive Plate Cables, Footswitches | | Class I
|
| Adhesive tape, | | Adhesive tape, | | Class I Devices |
| Adhesive | | Adhesive | | Class I Devices |
| Adjustable Chairs | | Adjustable Chairs | | Class I
|
| Adjustor-Pro Chiropractic Adjusting Instrument EL | | Adjustor-Pro Chiropractic Adjusting Instrument EL | | Class I
|
| Adjustor Pro - Chiropractic Adusting Instrument | | Adjustor Pro - Chiropractic Adusting Instrument | | Class I
|
| Administration Device | | Administration Device | | Class I
|
| Administrative risk-management information system application software | | Administrative risk-management information system application software | | Class I
|
| Adult drinking/feeding cup | | Adult drinking/feeding cup | | Class I
|
| Adult inguinal hernia truss | | Adult inguinal hernia truss | | Class I
|
| Adult nappy | | Adult nappy | | Class I
|
| Aerosol delivery tubing | | Aerosol delivery tubing | | Class IIa
|
| Aerosol face mask, non-rebreathing | | Aerosol face mask, non-rebreathing | | Class I
|
| Aerosol face mask, rebreathing, single-use | | Aerosol face mask, rebreathing, single-use | | Class I
|
| Aerosol face mask, rebreathing, single-use | | Aerosol face mask, rebreathing, single-use | | Class IIa
|
| Affective disorder therapy software | | Affective disorder therapy software | |
|
| Affective disorder therapy software | | Affective disorder therapy software | | Class I
|
| Agar dental impression material | | Agar dental impression material | |
|
| Aids For Daily Living (Bathing And Toilet) | | Aids For Daily Living (Bathing And Toilet) | | Class I
|
| Aids For Daily Living (Other) | | Aids For Daily Living (Other) | | Class I
|
| Aids For Daily Living (Seating And Support) | | Aids For Daily Living (Seating And Support) | | Class I
|
| Air-conduction hearing aid, behind-the-ear | | Air-conduction hearing aid, behind-the-ear | | Class I
|
| Air-conduction hearing aid, behind-the-ear | | Air-conduction hearing aid, behind-the-ear | | Class IIa
|
| Air-conduction hearing aid, canal | | Air-conduction hearing aid, canal | |
|
| Air-conduction hearing aid, in-the-ear | | Air-conduction hearing aid, in-the-ear | |
|
| Air-conduction hearing aid, receiver-in-canal | | Air-conduction hearing aid, receiver-in-canal | | Class IIa
|
| Air-filled bed mattress overlay | | Air-filled bed mattress overlay | | Class I
|
| Air-filled chair cushion | | Air-filled chair cushion | | Class I
|
| Airway device cleaning utensil, invasive | | Airway device cleaning utensil, invasive | | Class I
|
| Airway device cleaning utensil, invasive | | Airway device cleaning utensil, invasive | | Class IIa
|
| Airway device cleaning utensil, noninvasive, reusable | | Airway device cleaning utensil, noninvasive, reusable | | Class I
|
| Airway device cleaning utensil, noninvasive, single-use | | Airway device cleaning utensil, noninvasive, single-use | | Class I
|
| Airway Devices/Monitoring Equipment And Accessories | | Airway Devices/Monitoring Equipment And Accessories | | Class I
|
| Airway emergency clearance/suction plunger | | Airway emergency clearance/suction plunger | | Class I
|
| Airway obstruction forceps | | Airway obstruction forceps | | Class I
|
| Airway pressure alarm | | Airway pressure alarm | | Class I
|
| Airway pressure monitor, non-powered | | Airway pressure monitor, non-powered | |
|
| Airway pressure monitor, non-powered | | Airway pressure monitor, non-powered | | Class IIa
|
| Airway pressure monitor, powered | | Airway pressure monitor, powered | | Class IIa
|
| Airway pressure/oxygen monitor | | Airway pressure/oxygen monitor | | Class IIb
|
| Airway protection face mask | | Airway protection face mask | | Class I
|
| Airway suction catheter | | Airway suction catheter | | Class I
|
| Airway suction catheter | | Airway suction catheter | | Class IIa
|
| Airway tube forceps, reusable | | Airway tube forceps, reusable | | Class I
|
| Airway tube forceps, single-use | | Airway tube forceps, single-use | | Class I
|
| Alarm application software | | Alarm application software | | Class I
|
| Alcohol breath analyser | | Alcohol breath analyser | | Class IIa
|
| Alcohol Preparation Pads For Use For General Cleaning On Unbroken Skin (Not Measurable) | | Alcohol Preparation Pads For Use For General Cleaning On Unbroken Skin (Not Measurable) | | Class I
|
| Alcohol Wipes | | Alcohol Wipes | | Class I
|
| Alginate dental impression material | | Alginate dental impression material | |
|
| Alginate dental impression material | | Alginate dental impression material | | Class I
|
| Alkaline Detergent 9012 | | Alkaline Detergent 9012 | | Class I
|
| Allergen Resistant Bedding | | Allergen Resistant Bedding | | Class I
|
| Allergy testing lancet | | Allergy testing lancet | | Class IIa
|
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | |
|
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | | Class I
|
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | | Class I Devices |
| Alternating-pressure bed mattress overlay system | | Alternating-pressure bed mattress overlay system | | Class IIa
|
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | |
|
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | | Class I
|
| Alternating-pressure bed mattress system | | Alternating-pressure bed mattress system | | Class IIa
|
| Alternating-pressure bed mattress | | Alternating-pressure bed mattress | | Class I
|
| Alternating-pressure bed mattress | | Alternating-pressure bed mattress | | Class IIa
|
| Alternating-pressure chair cushion system | | Alternating-pressure chair cushion system | |
|
| Alternating-pressure chair cushion system | | Alternating-pressure chair cushion system | | Class I
|
| Alternating-pressure chair cushion, reusable | | Alternating-pressure chair cushion, reusable | | Class I
|
| Alternating-pressure pump | | Alternating-pressure pump | | Class I
|
| Ambulance stretcher, electrohydraulic | | Ambulance stretcher, electrohydraulic | | Class I
|
| Ambulance stretcher, manual | | Ambulance stretcher, manual | | Class I
|
| Ambulatory recorder conductive patch | | Ambulatory recorder conductive patch | | Class I Devices |
| Amniotic fluid leak detector | | Amniotic fluid leak detector | | Class I
|
| Amniotic membrane perforator, reusable | | Amniotic membrane perforator, reusable | | Class I
|
| Amniotic membrane perforator, single-use | | Amniotic membrane perforator, single-use | | Class I
|
| Amniotic trocar | | Amniotic trocar | | Class I Devices |
| Amniotome, reusable | | Amniotome, reusable | | Class I
|
| Amputation knife | | Amputation knife | | Class I
|
| Anaesthesia administration patient evaluation software | | Anaesthesia administration patient evaluation software | | Class I
|
| Anaesthesia administration support software | | Anaesthesia administration support software | |
|
| Anaesthesia breathing circuit, reusable | | Anaesthesia breathing circuit, reusable | | Class IIa
|
| Anaesthesia breathing circuit, single-use | | Anaesthesia breathing circuit, single-use | | Class I
|
| Anaesthesia breathing circuit, single-use | | Anaesthesia breathing circuit, single-use | | Class IIa
|
| Anaesthesia conduction filter | | Anaesthesia conduction filter | | Class I
|
| Anaesthesia face mask, reusable | | Anaesthesia face mask, reusable | | Class I
|
| Anaesthesia face mask, reusable | | Anaesthesia face mask, reusable | | Class IIa
|
| Anaesthesia face mask, single-use | | Anaesthesia face mask, single-use | | Class I
|
| Anaesthesia face mask, single-use | | Anaesthesia face mask, single-use | | Class IIa
|
| Anaesthesia information system application software | | Anaesthesia information system application software | |
|
| Anaesthesia mask strap, reusable | | Anaesthesia mask strap, reusable | | Class I
|
| Anaesthesia mask strap, reusable | | Anaesthesia mask strap, reusable | | Class IIa
|
| Anaesthesia mask strap, single-use | | Anaesthesia mask strap, single-use | | Class I
|
| Anaesthesia screen | | Anaesthesia screen | | Class I
|
| Anaesthesia ventilator | | Anaesthesia ventilator | | Class IIb
|
| Anaesthesia workstation gas scavenger | | Anaesthesia workstation gas scavenger | | Class I
|
| Anaesthesia workstation, closed-circuit | | Anaesthesia workstation, closed-circuit | | Class IIb
|
| Anaesthesia workstation, general-purpose | | Anaesthesia workstation, general-purpose | | Class IIb
|
| Anaesthetic devices and accessories | | Anaesthetic devices and accessories | | Class I
|
| Anaesthetic gas scavenging terminal unit | | Anaesthetic gas scavenging terminal unit | | Class IIa
|
| Anaesthetic Sundries | | Anaesthetic Sundries | |
|
| Anaesthetist's stool | | Anaesthetist's stool | |
|
| Anal plug, single-use | | Anal plug, single-use | | Class I
|
| Anal plug, single-use | | Anal plug, single-use | | Class IIa
|
| Analgesic implantable peripheral nerve electrical stimulation system | | Analgesic implantable peripheral nerve electrical stimulation system | | Class I
|
| Analgesic implantable peripheral nerve electrical stimulation system | | Analgesic implantable peripheral nerve electrical stimulation system | | Class IIa
|
| Analgesic implantable peripheral nerve electrical stimulation system | | Analgesic implantable peripheral nerve electrical stimulation system | | Class IIb
|
| Analgesic PENS system probe, single-use | | Analgesic PENS system probe, single-use | |
|
| Analgesic PENS system | | Analgesic PENS system | |
|
| Analgesic TENS system | | Analgesic TENS system | | Class I Devices |
| Analgesic transcutaneous electrical nerve stimulation system | | Analgesic transcutaneous electrical nerve stimulation system | | Class IIa
|
| Analytical non-scalp cutaneous electrode | | Analytical non-scalp cutaneous electrode | | Class I
|
| Analytical scalp electrode, reusable | | Analytical scalp electrode, reusable | | Class I Devices |
| Analytical scalp electrode, single-use | | Analytical scalp electrode, single-use | | Products Covered By Article 12 |
| Analytical scalp electrode, single-use | | Analytical scalp electrode, single-use | | Class I
|
| Aneroid manual sphygmomanometer | | Aneroid manual sphygmomanometer | | Class I
|
| Aneurysm clip applier | | Aneurysm clip applier | | Class I
|
| Angiographic syringe | | Angiographic syringe | | Class I Devices |
| Angiographic x-ray system application software | | Angiographic x-ray system application software | | Class I
|
| Angiography kit | | Angiography kit | |
|
| Angioplasty catheter connector | | Angioplasty catheter connector | | Class I Devices |
| Ankle-disarticulation prosthesis socket | | Ankle-disarticulation prosthesis socket | |
|
| Ankle-disarticulation prosthesis | | Ankle-disarticulation prosthesis | |
|
| Ankle binder, reusable | | Ankle binder, reusable | | Class I
|
| Ankle joint orthosis | | Ankle joint orthosis | |
|
| Ankle joint orthosis | | Ankle joint orthosis | | Class I
|
| Ankle prosthesis bearing | | Ankle prosthesis bearing | |
|
| Ankle prosthesis bearing | | Ankle prosthesis bearing | | Class IIb
|
| Ankle prosthesis trial | | Ankle prosthesis trial | |
|
| Ankle prosthesis trial | | Ankle prosthesis trial | | Class IIa
|
| Ankle/foot orthosis | | Ankle/foot orthosis | |
|