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Rodillera Envolvente articulación monocéntrica ELCROSS XL
EUDAMEDClass I (EU MDR)
Ref 124BG XL
by Prim, S.a.
Identity
- Trade Name
- Rodillera Envolvente articulación monocéntrica ELCROSS XL EUDAMED
- Device Name
- Ortesis de Rodilla EUDAMED
- Model / Reference
- 124BG XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048101139 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 monocéntrica 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 (2)
- EUDAMED 4f590c33-a006-4e04-ba27-51a0b417a652 61 fields · synced Oct 6, 2026
- EUDAMED 9b263dd9-5fa0-48ed-b7eb-b7286f5a7f7c 61 fields · synced Jul 31, 2026