Identity
- Trade Name
- Ortesis de hombro HSAFE EUDAMED
- Device Name
- Ortesis de Hombro-Codo EUDAMED
- Model / Reference
- HSAFE LR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680798525 EUDAMED
- Basic UDI-DI
- 843404825ORTESISHOMBROA5 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
Ortesis de hombro HSAFE 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 | 843404825ORTESISHOMBROA5 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED cb76d915-cc63-40e6-9516-597f66f703de 61 fields · synced Jun 17, 2026
- EUDAMED 4df1fcc7-2f8a-4d6d-bc47-e5e63d756daa 61 fields · synced Jun 11, 2026