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Ortesis Dorsolumbar ELCROSS Light XXL
EUDAMEDClass I (EU MDR)
Ref 2137N XXL
by Prim, S.a.
Identity
- Trade Name
- Ortesis Dorsolumbar ELCROSS Light XXL EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- 2137N XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680911276 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060609 WRIST (FOREARM) 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 Dorsolumbar ELCROSS Light XXL 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 752ed16b-678d-4baf-b5ca-529d7e8d4db0 61 fields · synced Jul 30, 2026
- EUDAMED 7780c7bb-5245-49de-8e7d-bc698ad6e627 61 fields · synced Jul 30, 2026