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Humerux
EUDAMEDClass I (EU MDR)
Ref EVOH300 SRef EVOH300 S C Ref EVOH300 L CRef EVOH300 XL LRef EVOH300 LRef EVOH300 M L Ref EVOH300 XL C
by Prim, S.a.
Identity
- Trade Name
- HUMERUX EUDAMED
- Device Name
- Ortesis de Brazo EUDAMED
- Model / Reference
- EVOH300 S EUDAMEDEVOH300 S C EUDAMEDEVOH300 L C EUDAMEDEVOH300 XL L EUDAMEDEVOH300 L EUDAMEDEVOH300 M L EUDAMEDEVOH300 XL C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048324897 EUDAMED08434048453467 EUDAMED08434048453504 EUDAMED08434048453535 EUDAMED08434048324910 EUDAMED08434048453498 EUDAMED08434048453528 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 (14)
- EUDAMED a1ee5f49-84cd-4799-82b0-a6246fc70ae5 61 fields · synced Jul 29, 2026
- EUDAMED 485fbc63-0210-4804-a311-02fd10dd8c19 61 fields · synced May 17, 2026
- EUDAMED defc1cbf-c784-4759-980e-121dfd7c434b 61 fields · synced May 17, 2026
- EUDAMED 4ccb60a0-7040-4d46-9977-9e98e0b5663e 61 fields · synced May 17, 2026
- EUDAMED 780df24f-5c16-4cee-bc8e-39d8ee26f236 61 fields · synced May 17, 2026
- EUDAMED ffbb8148-96de-414f-99e6-279891603cef 61 fields · synced May 18, 2026
- EUDAMED 35ad30e3-446f-4d7d-a190-d9797fd3d6bd 61 fields · synced May 18, 2026
- EUDAMED 8ff2c1b0-89a8-4494-82f5-db65265c3a5a 61 fields · synced Jun 19, 2026
- EUDAMED 5c633749-e2fa-4946-810c-cc560248bef5 61 fields · synced Jul 9, 2026
- EUDAMED 3e566cd3-9a62-4335-9c8d-51be6d7c15b4 61 fields · synced Jul 12, 2026
- EUDAMED db3092b7-6c4f-4c81-ad95-b4854a075155 61 fields · synced Jul 13, 2026
- EUDAMED a112bbfb-14b9-40f2-ab57-ce0db65e311c 61 fields · synced Jul 17, 2026
- EUDAMED 2299b2b1-9515-4c32-b003-a2620d5c9f92 61 fields · synced Jul 28, 2026
- EUDAMED b75c6cbf-d126-49b6-8d06-d0958ed5f0b8 61 fields · synced Jul 29, 2026