Identity
- Trade Name
- directSTIM Adjustable Harness EUDAMED
- Device Name
- Adjustable Harness EUDAMED
- Model / Reference
- 12320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640183760112 EUDAMED
- Basic UDI-DI
- B-07640183760112 EUDAMED
- EMDN Code
- J020780 NEUROSTIMULATORS PROGRAMMERS - HARDWARE ACCESSORIES 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 Adjustable Harness 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-07640183760112 | 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 526f7143-c4d3-4f54-93d0-eafba2650a2d 61 fields · synced Jul 9, 2026