Identity
- Trade Name
- HUMERUX EUDAMED
- Device Name
- Ortesis de Brazo EUDAMED
- Model / Reference
- EVOH300 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048324927 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 3070024b-7b31-4d17-926d-0b1773e60b7c 61 fields · synced Jun 18, 2026
- EUDAMED b9e9773d-f964-4e39-8f2b-7155ea379e3e 61 fields · synced Jun 18, 2026