Identity
- Trade Name
- ProfiTEX Lombosacral-LombsVIII EUDAMED
- Device Name
- Orteză lombosacrală EUDAMED
- Model / Reference
- 4X.L-023-VIII EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944784004449 EUDAMED
- Basic UDI-DI
- 5944784ORTPTCVLOMOSACRACM EUDAMED
- Direct Marketing DI
- 05944784004449 EUDAMED
- EMDN Code
- Y060308 LUMBOSACRAL SPINE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
ProfiTEX Lombosacral-LombsVIII by OrtoProfil Prod Romania SRL — 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 | 5944784ORTPTCVLOMOSACRACM | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrtoProfil Prod Romania SRL
- EUDAMED SRN
- RO-MF-000000526
Sources (1)
- EUDAMED f8343457-e68b-4b63-8417-b1628dccb9f1 61 fields · synced Oct 6, 2026