Identity
- Trade Name
- directSTIM 12-electrode lead EUDAMED
- Device Name
- directSTIM 12-electrode lead kit EUDAMED
- Model / Reference
- 11500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640183760013 EUDAMED
- Basic UDI-DI
- B-07640183760013 EUDAMED
- EMDN Code
- J020102 DEEP BRAIN STIMULATION (DBS) LEADS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
directSTIM 12-electrode lead 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-07640183760013 | 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 16e58eec-50aa-48b1-81af-86dafe8004a1 61 fields · synced Jul 17, 2026