Identity
- Trade Name
- HUMERUX EUDAMED
- Device Name
- Ortesis de Brazo EUDAMED
- Model / Reference
- EVOH300 M C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048453481 EUDAMED
- Basic UDI-DI
- 843404825ORTESISBRAZOW3 EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Humerux 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 | 843404825ORTESISBRAZOW3 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED a0d34858-5f7f-42b2-8fa0-59fa45ee89fe 61 fields · synced Jun 19, 2026
- EUDAMED e83702e9-afce-482c-a1e2-a1a62f27523a 61 fields · synced Jun 19, 2026