1(a) A non-invasive device to be used as a mechanical barrier or for compression or for absorption of exudates—Class A.
2(a) A non-invasive device used to channel or store body liquids or tissues, liquids or gases that are to be infused, administered or introduced into a patient—Class A.
A non-invasive device is Class A, unless the device is classified at a higher level under another rule.
5(a) Invasive devices that are not connected to an active medical device, or are intended for connection to a Class A medical device only and are for transient use—Class A.
5(c) Invasive devices that are for short-term use in the oral cavity as far as the pharynx, in an ear canal to the ear drum, or in a nasal cavity—Class A.
6(b) A reusable surgical instrument—Class A.
An active device is Class A, unless the device is classified at a higher level under another rule.
14(b) Devices that only contains animal tissues that have been rendered non-viable and the device is only intended by the manufacturer to come into contact with intact skin – Class A
15(c) A device specifically for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses - Class C.
Note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class A.
|active devices for recording|
|Adhesive dressing strip—not sterile|
|administration sets for gravity infusion|
|cervical collars and gravity traction devices or compression hosiery|
|Compression bandage used for sprains|
|Dental curing lights|
|dental impression materials|
|dental patient chairs|
|dentures removable by the patient|
|diagnostic devices for thermography|
|dressing for nose bleeds|
|handheld dental mirrors|
|leather straps associated with limb prostheses|
|processing or viewing of diagnostic images|
|prostatic balloon dilation catheters|
|syringes without needles|
|urine collection bottles|
|wound drainage collection bottles and incontinence pads|
|wound strips and gauze dressings to act as a barrier or absorb exudates from the wound|
|wound strips and gauze dressings to act as a barrier or absorb exudates from the wound.|