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Articulación de Tobillo
EUDAMEDClass I (EU MDR)
Ref D10 1P Ref D10 2P
by Prim, S.a.
Identity
- Trade Name
- Articulación de Tobillo EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- D10 1P EUDAMEDD10 2P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680759199 EUDAMED08426680759205 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT 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
Articulación de Tobillo 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 | 843404825ORTESISTOBILLOTM | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED 34dc508c-c934-4ea7-b37b-0bc3112457ba 61 fields · synced Jul 14, 2026
- EUDAMED bb05155a-196c-4f73-85ce-b2afe873ad12 61 fields · synced May 18, 2026