Identity
- Trade Name
- Férula Oppenheimer MR EUDAMED
- Device Name
- Ortesis de Mano, Muñeca y/o Dedos EUDAMED
- Model / Reference
- C6 MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680613651 EUDAMED
- Basic UDI-DI
- 843404825ORTESISMANOSXD EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Férula Oppenheimer MR by Prim S.a. — 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 | 843404825ORTESISMANOSXD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED c2d921c9-ca5c-4866-b19a-79c8b723f7e6 61 fields · synced Jul 19, 2026