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AIRTEX Rodillera larga semi abierta ROM con soporte y cinchas
EUDAMEDClass I (EU MDR)
Ref T151 XXLRef T151 XLRef T151 LRef T151 SRef T151 M
by Prim, S.a.
Identity
- Trade Name
- AIRTEX Rodillera larga semi abierta ROM con soporte y cinchas EUDAMEDAIRTEX Rodillera larga semi abierta ROM con soporte y cinchas L EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- T151 XXL EUDAMEDT151 XL EUDAMEDT151 L EUDAMEDT151 S EUDAMEDT151 M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048047444 EUDAMED08434048047437 EUDAMED08434048047406 EUDAMED08434048047420 EUDAMED08434048047413 EUDAMED
- Basic UDI-DI
- 843404825ORTESISRODILLASD EUDAMED
- EMDN Code
- Y061209 KNEE 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
AIRTEX Rodillera larga semi abierta ROM con soporte y cinchas 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 | 843404825ORTESISRODILLASD | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (10)
- EUDAMED fcf363e8-97bb-4c03-9042-0eeec0cbeb75 61 fields · synced Oct 6, 2026
- EUDAMED 7d66e9ae-aa89-4f8b-985b-a1389c7d8888 61 fields · synced May 17, 2026
- EUDAMED 055dfd27-18ce-4ec1-892c-76c8e7d8b9a5 61 fields · synced May 18, 2026
- EUDAMED 0ffca723-2673-41f0-84d6-1d0fd8c73136 61 fields · synced May 19, 2026
- EUDAMED 0d759fa2-4dfa-468a-8b2e-093da8d8b842 61 fields · synced May 19, 2026
- EUDAMED 8baf4320-12f2-4c6c-a612-e8e184d2a503 61 fields · synced Jul 21, 2026
- EUDAMED 9daae4be-3f30-49ab-ab73-13f403a63e23 61 fields · synced Jul 23, 2026
- EUDAMED 5bcbc92e-c4b3-4de6-8129-bfc60a7421cf 61 fields · synced Jul 26, 2026
- EUDAMED 66195245-86c5-4769-8a2a-6f5ab61831cd 61 fields · synced Jul 31, 2026
- EUDAMED ed75c57f-6d01-4d8b-9c87-4cbd855d706b 61 fields · synced Sep 18, 2026