← Back to catalogue
directSTIM 24-channel Implantable Pulse Generator
EUDAMEDClass AIMDD (EU MDR)
Ref 12000
Identity
- Trade Name
- directSTIM 24-channel Implantable Pulse Generator EUDAMED
- Device Name
- directSTIM 24-channel Implantable Pulse Generator EUDAMED
- Model / Reference
- 12000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640183760020 EUDAMED
- Basic UDI-DI
- B-07640183760020 EUDAMED
- EMDN Code
- J02010101 DEEP BRAIN STIMULATION (DBS) IMPLANTABLE NEUROSTIMULATORS, RECHARGEABLE EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
directSTIM 24-channel Implantable Pulse Generator by Aleva Neurotherapeutics SA — Class AIMDD — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640183760020 | Class AIMDD | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aleva Neurotherapeutics SA
- EUDAMED SRN
- CH-MF-000015804
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (1)
- EUDAMED be5a6beb-b209-469a-956a-295953f2340d 61 fields · synced Jun 18, 2026