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PRIM Walker Fijo EXP
EUDAMEDClass I (EU MDR)
Ref W100. L Ref W100. M
by Prim, S.a.
Identity
- Trade Name
- PRIM Walker Fijo EXP EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- W100. L EUDAMEDW100. M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048363780 EUDAMED08434048363773 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTOBILLOTM EUDAMED
- EMDN Code
- Y06120602 ENERGY RETURN ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 EXP 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 f2721b45-4f27-4886-b8be-0abbd9587df7 61 fields · synced Jul 14, 2026
- EUDAMED d6a7eca6-1272-4a6b-a071-1ef0e0668022 61 fields · synced May 19, 2026