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Ortesis Toraco-Lumbar Rígida SPINAIR SP500
EUDAMEDClass I (EU MDR)
Ref SP500 L2
by Prim, S.a.
Identity
- Trade Name
- Ortesis Toraco-Lumbar Rígida SPINAIR SP500 EUDAMED
- Device Name
- ORTESIS DE COLUMNA:CORSÉS EUDAMED
- Model / Reference
- SP500 L2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048110933 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 378a3cfb-7e9a-432b-b5bb-d6fff129a285 61 fields · synced Oct 6, 2026
- EUDAMED cf02b931-9f14-401c-a307-20ac72584c27 61 fields · synced Jul 29, 2026