Identity
- Trade Name
- directSTIM Clinician Programmer EUDAMED
- Device Name
- directSTIM Clinician Programmer EUDAMED
- Model / Reference
- 12200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640183760044 EUDAMED
- Basic UDI-DI
- B-07640183760044 EUDAMED
- EMDN Code
- J020701 NEUROSTIMULATORS PROGRAMMERS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
directSTIM Clinician Programmer 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-07640183760044 | 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 c60cd30e-10d4-4d0e-aaf2-619e7926110f 61 fields · synced Jun 19, 2026