SECTION 2: DESCRIPTION OF DEVICE Please provide a full description of the device which demonstrates that the product is covered under Directive 93/42/EEC: Device Description: SECTION 3: INTENDED USE OF THE DEVICE Please enter a full description of the intended use of the device, which supports the product classification: 1. List of any contra-indications : 2. List of any precautions / warnings : 3. Section 4: Previous Existing Legislation Does the device have any existing approvals (e.g. FDA 1. Yes No 510(k)) 2. If “Yes” – please advise Does this product, labelled with your Name & Address carry 3. Yes No CE Marking with another Notified Body
SECTION 2: DESCRIPTION OF DEVICE Please provide a full description of the device which demonstrates that the product is covered under Directive 93/42/EEC: Device Description: SECTION 3: INTENDED USE OF THE DEVICE 1. Please enter a full description of the intended use of the device, which supports the product classification: 2. List of any contra-indications : 3. List of any precautions / warnings : Section 4: Previous Existing Legislation 1. Does the device have any existing approvals (e.g. FDA 510(k)) Yes No 2. If “Yes” – please advise 3. Does this product, labelled with your Name & Address carry CE Marking with another Notified Body Yes No
GRF-25-40a.docx