Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Charging System
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340011
- Basic UDI-DI Code
- B-10810005340011
- Reference
- 1401
- Device Types
- None provided
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Charging System (CS, Model 1401) includes a Charging Device (CD), Dock, Charge Belt, and Power Supply. The Charging Device is a body worn device powered by a rechargeable battery and is used for transcutaneous charging of the implanted neurostimulator. The Charger can be held in place using the Charge Belt or an adhesive carrier. The Dock stores and recharges the Charger. The Power Supply is used to power the Dock.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J020480 | SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| AIMDD Annex II (excluding section 4) | 639686 | BSI Group The Netherlands B.V. | |
| AIMDD Annex II Section 4 | 634655 | BSI Group The Netherlands B.V. |
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