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AIRTEX Rodillera Policéntrica S
EUDAMEDClass I (EU MDR)
Ref ATX721 S
by Prim, S.a.
Identity
- Trade Name
- AIRTEX Rodillera Policéntrica S EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- ATX721 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048476855 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 Policéntrica S 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 (2)
- EUDAMED 45a1bb63-5c21-4699-a892-22627d03d3ef 61 fields · synced Jun 18, 2026
- EUDAMED 29f8f57d-55e1-4f1e-aff9-b2b0c3f6419c 61 fields · synced Jun 11, 2026