Identity
- Trade Name
- PRIM Walker Fijo EUDAMEDPRIM Walker Fijo XL EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- W100 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048355235 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
PRIM Walker Fijo 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 656c0491-d93a-4989-a230-faa0c936f1d1 61 fields · synced Jun 18, 2026
- EUDAMED 2d2a24c0-e58a-4dc6-8187-83d515f58728 61 fields · synced Jun 18, 2026