Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Remote Control
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340103
- Basic UDI-DI Code
- B-10810005340103
- Reference
- 2301
- Device Types
- None provided
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Axonics Remote Control (Model 2301) is a a non-rechargeable battery-powered device that uses radio-frequency (RF) signals to communicate with the Neurostimulator. The RC allows the subject to check and adjust the stimulation level, to check the status of the Neurostimulator battery charge level and to turn stimulation on or off.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J020480 | SACRAL SPINE IMPLANTABLE NEUROSTIMULATORS - ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| AIMDD Annex II Section 4 | 634655 | BSI Group The Netherlands B.V. | |
| AIMDD Annex II (excluding section 4) | 639686 | BSI Group The Netherlands B.V. |
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