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Faja Sacrolumbar AIRTEX OS, beige
EUDAMEDClass I (EU MDR)
Ref OST255BG
by Prim, S.a.
Identity
- Trade Name
- Faja Sacrolumbar AIRTEX OS, beige EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- OST255BG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048066315 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
Faja Sacrolumbar AIRTEX OS, beige 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 3e8d3d7e-3a15-48aa-a914-20b0095bfe65 61 fields · synced Jul 13, 2026
- EUDAMED 7267128e-409d-49f4-aafd-0750e060755a 61 fields · synced Jul 13, 2026