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Ortesis Dorsolumbar ELCROSS Light XL
EUDAMEDClass I (EU MDR)
Ref 2137N XL
by Prim, S.a.
Identity
- Trade Name
- Ortesis Dorsolumbar ELCROSS Light XL EUDAMED
- Device Name
- Fajas EUDAMED
- Model / Reference
- 2137N XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08426680902717 EUDAMED
- Basic UDI-DI
- 843404825FAJAC4 EUDAMED
- EMDN Code
- Y060309 THORACOLUMBOSACRAL 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 Dorsolumbar ELCROSS Light XL 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 237c8bb7-9d27-44df-bfa9-83d3b1729d77 61 fields · synced Jul 27, 2026
- EUDAMED ab2baf70-efb2-440e-bbac-8065bb404c49 61 fields · synced Jul 27, 2026