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AIRTEX Rodillera corta semi abierta ROM con soporte y cinchas
EUDAMEDClass I (EU MDR)
Ref T150 XXLRef T150 XLRef T150 S
by Prim, S.a.
Identity
- Trade Name
- AIRTEX Rodillera corta semi abierta ROM con soporte y cinchas EUDAMEDAIRTEX Rodillera corta semi abierta ROM con soporte y cinchas XXL EUDAMEDRodillera semi abierta ROM con soporte y cinchas, corta AIRTEX S EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- T150 XXL EUDAMEDT150 XL EUDAMEDT150 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048047642 EUDAMED08434048047635 EUDAMED08434048047628 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 corta 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 (4)
- EUDAMED 7f8dab66-b1ad-4223-bc9b-47a50f2d2709 61 fields · synced Oct 6, 2026
- EUDAMED 83471848-7f96-4965-bf54-b4104fbc6896 61 fields · synced May 18, 2026
- EUDAMED 99dd7c8c-005b-4cf6-949d-c0823f10c39b 61 fields · synced Jul 15, 2026
- EUDAMED 1d64adea-7db9-4812-b572-7cda4655a5f9 61 fields · synced Jul 15, 2026