Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Accessory, Charging Belt - Extended Size
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340271
- Basic UDI-DI Code
- B-10810005340271
- Reference
- 9008-E
- Device Types
- None provided
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Accessories Kit provide individually packaged surplus components of the Axonics Sacral Neuromodulation System. These components are used in the implantation and operation of the Axonics Sacral Neuromodulation System . Refer to the appropriate product manual for each accessory for the instructions for use, indications, warning, and precautions, and additional information.
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. |
Similar Devices
Other on-the-market devices with the same classification (Eu Aimdd Class) and regulation (EU AIMDD).
directSTIM 12-electrode lead
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 24-channel Implantable Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 12-connector extension
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Clinician Programmer
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Patient Programmer Charger kit
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM External Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market