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Accesorio: Espaldera Optima gris
EUDAMEDClass I (EU MDR)
Ref ESPONEG
by Prim, S.a.
Identity
- Trade Name
- Accesorio: Espaldera Optima gris EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- ESPONEG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048002627 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060380 SPINAL ORTHOSES - ACCESSORIES 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
Accesorio: Espaldera Optima gris 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 | 843404825FAJAC4 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED b56cf788-9eb3-4875-84a4-3452c112504d 61 fields · synced Jul 10, 2026
- EUDAMED ec9c4e9b-613c-459c-997a-2126b9a65943 61 fields · synced Jul 10, 2026