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Ortesis Sacrolumbar Alta ELCROSS Light M
EUDAMEDClass I (EU MDR)
Ref 2133N M
by Prim, S.a.
Identity
- Trade Name
- Ortesis Sacrolumbar Alta ELCROSS Light M EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- 2133N M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680902656 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 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 Sacrolumbar Alta ELCROSS Light M 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 (2)
- EUDAMED 53b11b34-2989-4aae-96cd-62a75da43c12 61 fields · synced Jun 19, 2026
- EUDAMED b9e5709f-0284-4b60-b446-6d829e7c019a 61 fields · synced Jun 19, 2026