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PRIM Walker AIR
EUDAMEDClass I (EU MDR)
Ref W100H L Ref W100H XLRef W100H S
by Prim, S.a.
Identity
- Trade Name
- PRIM Walker AIR EUDAMED
- Device Name
- Ortesis de Tobillo EUDAMED
- Model / Reference
- W100H L EUDAMEDW100H XL EUDAMEDW100H S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680888448 EUDAMED08434048355242 EUDAMED08426680888424 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 AIR 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 (3)
- EUDAMED 92b493ab-c9a9-4009-9c4c-92a06ec1433e 61 fields · synced Jul 14, 2026
- EUDAMED 3c2ddb7a-faaf-4db3-93ec-b347cae83bdf 61 fields · synced May 18, 2026
- EUDAMED 7487eef8-99f8-4fe3-afdb-cb6d04af1ebf 61 fields · synced May 19, 2026