Identity
- Trade Name
- FYN ELBOW EUDAMED
- Device Name
- FYN ELBOW EUDAMED
- Model / Reference
- FYN ELBOW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701459811410 EUDAMED03701459811441 EUDAMED
- Basic UDI-DI
- 37014598MACG3D002STK4 EUDAMED
- EMDN Code
- Y060619 ELBOW-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 Elbow 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 | 37014598MACG3D002STK4 | Class I | Active |
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Manufacturer
- Manufacturer
- Groupe Sober Sas
- EUDAMED SRN
- FR-MF-000017818
Sources (2)
- EUDAMED dc073072-4e05-4243-81a0-6833953ccc7f 61 fields · synced Jul 24, 2026
- EUDAMED e7fb0185-dbd2-4c96-9887-023835c545fc 61 fields · synced May 19, 2026