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AIRTEX Ginocchiera
EUDAMEDClass I (EU MDR)
Ref UNI-K30BRef UNI-K30
by Prim, S.a.
Identity
- Trade Name
- AIRTEX Ginocchiera EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- UNI-K30B EUDAMEDUNI-K30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048188543 EUDAMED08434048029662 EUDAMED
- Basic UDI-DI
- 843404825ORTESISRODILLASD EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Ginocchiera 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 2fc1c736-f689-4fb1-998e-3b25206d42d2 61 fields · synced Jul 28, 2026
- EUDAMED f9a52add-78d7-4975-bf48-5580ebb2be7e 61 fields · synced May 18, 2026