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CLUBAX Ajustable
EUDAMEDClass I (EU MDR)
Ref C12 RRef C12 LRef C11 L
by Prim, S.a.
Identity
- Trade Name
- CLUBAX Ajustable EUDAMED
- Device Name
- Ortesis Tibiales EUDAMED
- Model / Reference
- C12 R EUDAMEDC12 L EUDAMEDC11 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680668569 EUDAMED08426680668576 EUDAMED08426680668552 EUDAMED
- Basic UDI-DI
- 843404825ORTESISTIBIAXY EUDAMED
- EMDN Code
- Y061218 HIP-KNEE-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
CLUBAX Ajustable 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 | 843404825ORTESISTIBIAXY | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (3)
- EUDAMED 1e151600-c4e7-45da-b286-d816b62bc6d8 61 fields · synced Jul 27, 2026
- EUDAMED 1d7a5454-4505-40d1-ab77-7ac321ddd8d1 61 fields · synced May 18, 2026
- EUDAMED 1d523a34-8b23-41bf-b868-92fe1dbd0ce8 61 fields · synced May 18, 2026