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Ortesis de hombro HSAFE
EUDAMEDClass I (EU MDR)
Ref HSAFE SLRef HSAFE SRRef HSAFE MR
by Prim, S.a.
Identity
- Trade Name
- Ortesis de hombro HSAFE EUDAMED
- Device Name
- Ortesis de Hombro-Codo EUDAMED
- Model / Reference
- HSAFE SL EUDAMEDHSAFE SR EUDAMEDHSAFE MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680798471 EUDAMED08426680798501 EUDAMED08426680798518 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 (6)
- EUDAMED 1189093f-2b5c-4440-ba86-984eac3c6b0f 61 fields · synced Jul 16, 2026
- EUDAMED 9ec6ccba-1995-4e02-bd36-5071843ea9c6 61 fields · synced May 18, 2026
- EUDAMED 048074fa-8c93-4150-99a0-76bccf459f31 61 fields · synced May 18, 2026
- EUDAMED 5fd1968c-1270-4533-a6ab-a9aa9e13d4bd 61 fields · synced Jul 9, 2026
- EUDAMED ac196249-9bc0-4351-bdda-f8ac6869934a 61 fields · synced Jul 12, 2026
- EUDAMED 28f30576-aa99-427a-b4b9-d92a1fd0e414 61 fields · synced Jul 16, 2026