Identity
- Trade Name
- FYN WRIST EUDAMED
- Device Name
- FYN WRIST EUDAMED
- Model / Reference
- FYN WRIST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701459811557 EUDAMED
- Basic UDI-DI
- 37014598POIG3D002ST74 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fyn Wrist by Groupe Sober Sas — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 37014598POIG3D002ST74 | Class I | Active |
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Manufacturer
- Manufacturer
- Groupe Sober Sas
- EUDAMED SRN
- FR-MF-000017818
Sources (1)
- EUDAMED b47c8083-4a7e-45a5-8789-f10ab1995a7b 61 fields · synced Jul 21, 2026