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Ortesis Sacrolumbar media ELCROSS Lux
EUDAMEDClass I (EU MDR)
Ref 2132LUX SRef 2132LUX XLRef 2132GLUX MRef 2132LUX LRef 2132GLUX LRef 2132LUX MRef 2132GLUX XLRef 2132GLUX XXL
by Prim, S.a.
Identity
- Trade Name
- Ortesis Sacrolumbar media ELCROSS Lux EUDAMEDOrtesis Sacrolumbar media ELCROSS Lux, Gris EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- 2132LUX S EUDAMED2132LUX XL EUDAMED2132GLUX M EUDAMED2132LUX L EUDAMED2132GLUX L EUDAMED2132LUX M EUDAMED2132GLUX XL EUDAMED2132GLUX XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048084517 EUDAMED08434048084524 EUDAMED08434048111091 EUDAMED08434048084494 EUDAMED08434048111084 EUDAMED08434048084500 EUDAMED08434048111114 EUDAMED08434048111121 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDItaly 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 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 (8)
- EUDAMED b1264393-e2df-46ae-8b4c-abec90a9d71c 61 fields · synced Jul 30, 2026
- EUDAMED 015cbc5c-90c1-4ae3-8f5a-27bee077dcde 61 fields · synced May 16, 2026
- EUDAMED 3f35b05d-e95b-4fc3-9dd7-1abe2e3e66f6 61 fields · synced May 17, 2026
- EUDAMED 89a250b7-ff34-4b73-8e5e-f088975703e4 61 fields · synced May 17, 2026
- EUDAMED 885d8eb0-f2f0-4d94-a6cf-086650245aaf 61 fields · synced May 17, 2026
- EUDAMED 6fc62444-23c9-4370-b941-ae35a7b41c32 61 fields · synced May 18, 2026
- EUDAMED 330ef13c-af8e-44aa-9c9f-7c380f108746 61 fields · synced May 18, 2026
- EUDAMED 1977f546-cbc1-4317-a675-0bf5e750967b 61 fields · synced May 19, 2026