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Ortesis Toraco-Lumbar Rígida SPINAIR SP500
EUDAMEDClass I (EU MDR)
Ref SP500 M2
by Prim, S.a.
Identity
- Trade Name
- Ortesis Toraco-Lumbar Rígida SPINAIR SP500 EUDAMED
- Device Name
- ORTESIS DE COLUMNA:CORSÉS EUDAMED
- Model / Reference
- SP500 M2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048110964 EUDAMED
- Basic UDI-DI
- 843404825CORSECX EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL 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 Toraco-Lumbar Rígida SPINAIR SP500 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 (2)
- EUDAMED 36737ce2-059a-4850-978c-458f5a12de39 61 fields · synced Jun 18, 2026
- EUDAMED 532c8495-2693-43d3-8e1e-c054bdb22840 61 fields · synced Jun 18, 2026