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Ortesis Lumbosacra Baja PRIMSPINE FOCUS
EUDAMEDClass I (EU MDR)
Ref PRS661 MRef PRS661 SRef PRS661 LRef PRS661 XL
by Prim, S.a.
Identity
- Trade Name
- Ortesis Lumbosacra Baja PRIMSPINE FOCUS EUDAMED
- Device Name
- ORTESIS DE COLUMNA:CORSÉS EUDAMED
- Model / Reference
- PRS661 M EUDAMEDPRS661 S EUDAMEDPRS661 L EUDAMEDPRS661 XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048385102 EUDAMED08434048385096 EUDAMED08434048385119 EUDAMED08434048385126 EUDAMED
- Basic UDI-DI
- 843404825CORSECX EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE 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 Lumbosacra Baja PRIMSPINE FOCUS 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 | 843404825CORSECX | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (4)
- EUDAMED 0ea80ece-eaf0-44bc-9b76-1da34340e6d0 61 fields · synced Jul 27, 2026
- EUDAMED bdf98bb7-bbd9-436a-b9b4-2905ca5b505d 61 fields · synced May 17, 2026
- EUDAMED 0e1aa18b-0cde-4651-90e4-68fb32c57c98 61 fields · synced May 18, 2026
- EUDAMED 3a659931-4266-480e-947e-989d1ed82034 61 fields · synced May 19, 2026