Eu Aimdd
Eu Aimdd Class
On The Market
🇨🇭 Switzerland
directSTIM 12-electrode lead
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 07640183760013
- Basic UDI-DI Code
- B-07640183760013
- Reference
- 11500
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Aimdd
- Classification
- Eu Aimdd Class
- Status
- On The Market
- Manufacturer
- Aleva Neurotherapeutics SA
Additional Description
The directSTIM lead is an implantable component of the directSTIM DBS System. The direcSTIM lead connects to the IPG through an extension. The directSTIM lead runs subcutaneously from the parietal bone up to the frontal area of the skull where it enters into the brain up to the target area.
CND Nomenclature Codes
| Code | Description |
|---|---|
| J020102 | DEEP BRAIN STIMULATION (DBS) LEADS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| AIMDD Annex II (excluding section 4) | 2223241CE01 | DEKRA Certification B.V. | Expired |
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