Identity
- Trade Name
- directSTIM External Pulse Generator EUDAMED
- Device Name
- directSTIM External Pulse Generator EUDAMED
- Model / Reference
- 12400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640183760068 EUDAMED
- Basic UDI-DI
- B-07640183760068 EUDAMED
- EMDN Code
- J020199 CEREBRAL IMPLANTABLE NEUROSTIMULATORS - OTHER EUDAMED
Classification
- Device Class
- Class AIMDD EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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 External 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-07640183760068 | Class AIMDD | Active |
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Manufacturer
- Manufacturer
- Aleva Neurotherapeutics SA
- EUDAMED SRN
- CH-MF-000015804
- Authorised Representative
- Veranex Germany GmbH DE-AR-000005578
Sources (1)
- EUDAMED 1a23e236-8209-4194-b64a-e2dbd498d5e5 61 fields · synced Jun 19, 2026