ProfiTEX Lombosacral-Lombs I
by OrtoProfil Prod Romania SRL EUDAMED
Active
Ref 4X.L-023-I
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5944784ORTPTCVLOMOSACRACM | Date25 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Orteză lombosacrală
- Model / Reference
- 4X.L-023-I
- Primary DI / UDI-DI
- 05944784004487
- Basic UDI-DI
- 5944784ORTPTCVLOMOSACRACM
- Direct Marketing DI
- 05944784004487
- EMDN Code
- Y060308 Lumbosacral spine orthoses
- Device Class
- Class I
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000000526
Other devices from OrtoProfil Prod Romania SRL
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No