Identity
- Trade Name
- ELCROSS LUX ESPALDILLERA EUDAMED
- Device Name
- ESPALDILLERA EUDAMED
- Model / Reference
- 3138BG XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08434048330843 EUDAMED
- Basic UDI-DI
- 843404825ESPALDILLERA38 EUDAMED
- EMDN Code
- Y060307 THORACIC 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
Elcross Lux Espaldillera 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 | 843404825ESPALDILLERA38 | Class I | Active |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (1)
- EUDAMED 92c98756-535e-4c5e-b5f4-7e6a96a8261a 61 fields · synced Jun 18, 2026