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Ortesis Sacrolumbar media ELCROSS Lux, Gris
EUDAMEDClass I (EU MDR)
Ref 2132GLUX S
by Prim, S.a.
Identity
- Trade Name
- Ortesis Sacrolumbar media ELCROSS Lux, Gris EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- 2132GLUX S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048111107 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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 Sacrolumbar media ELCROSS Lux, 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 (1)
- EUDAMED 07f66bd9-36f5-4055-bf3d-6a574e42ff82 61 fields · synced Jun 18, 2026