| Device applicable legislation |
MDR (REGULATION (EU) 2017/745 on medical devices) |
| Device Basic UDI-DI code/issuing entity |
5065010064CUE1P4/GS1 |
| UDI-DI code/issuing entity |
05065010064003/GS1 |
| Device authorised representative |
IE-AR-000003999—European Healthcare & Device Solutions, Stratton House, Bishopstown Road, Cork, Ireland |
| Device risk class |
Class I |
| Device nomenclature code(s) |
Z12101106: Neurological stimulators |
| Device additional information URL |
https://charconeurotech.com/
|
| Is the device implantable? |
No |
| Does the device measure function? |
No |
| Is the device or does the device include a reusable surgical instrument? |
No |
| Is this an active device? |
Yes |
| Does the device intend to administer and/or remove medicinal products? |
No |
| Device model |
CUE1+ |
| Device name/trade name |
CUE1+ for Parkinson’s |
| Does the device involve the presence of human tissues and cells or their derivatives? |
No |
| Does the device involve the presence of animal tissues and cells or their derivatives? |
No |
| Company, producer of the CUE1+ device |
Charco Neurotech Ltd |
| Website for producer of CUE1+ device |
www.charconeurotech.com
|
