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Rodillera Envolvente articulación policéntrica ELCROSS XL
EUDAMEDClass I (EU MDR)
Ref 128BG XL
by Prim, S.a.
Identity
- Trade Name
- Rodillera Envolvente articulación policéntrica ELCROSS XL EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- 128BG XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048101184 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
Rodillera Envolvente articulación policéntrica ELCROSS XL 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 (1)
- EUDAMED 75449691-1e9a-4132-bcef-769a32574e11 61 fields · synced Oct 6, 2026