Eu Aimdd
Eu Aimdd Class
On The Market
๐บ๐ธ United States
Axonics Neurostimulator
Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
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Basic Information
- Primary DI
- 10810005340066
- Basic UDI-DI Code
- B-10810005340066
- Reference
- 1101
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Axonics Inc.
Additional Description
The Axonics Neurostimulator (also known as IPG) is a rechargeable implanted device that provides electrical pulses to stimulate the target sacral nerve.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J020402 | INTESTINAL INCONTINENCE NEUROSTIMULATORS |
| J020401 | BLADDER INCONTINENCE NEUROSTIMULATORS |
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. |
Available In Countries
๐ณ๐ฑ Netherlands
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