Eu Aimdd
Eu Aimdd Class
On The Market
🇺🇸 United States
Axonics Trial Stimulator
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 10810005340059
- Basic UDI-DI Code
- B-10810005340059
- Reference
- 1601
- Device Types
-
Single use
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
Additional product description: Trial Stimulator (also known as External Pulse Generator or EPG) is a single-use, non-rechargeable body worn device that provides electrical pulses to stimulate the S3 sacral nerve which are transferred to the region of therapy by a PNE Lead via a Basic Trial Cable or by a Tined Lead via a Percutaneous Extension cable. An EPG belt around is used to place the EPG the patient’s abdomen-hip area.
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