Identity
- Trade Name
- ORTESIS DORSIFLEX.MUÑECA C/S ART.MET. EUDAMED
- Device Name
- ORTESIS DORSIFLEX.MUÑECA C/S ART.MET. EUDAMED
- Model / Reference
- X-5032- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08431184503209 EUDAMED
- Basic UDI-DI
- 8431184X5032QA EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS 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
Ortesis Dorsiflex.muñeca C/S Art.met. by Ortoiberica S.L. — 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 | 8431184X5032QA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortoiberica S.L.
- EUDAMED SRN
- ES-MF-000025780
Sources (1)
- EUDAMED 5015db1e-6ada-4814-b0a2-881d4a5612b5 61 fields · synced Jun 18, 2026