Specification of CUE1+ device
| 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 |