ProfiTEX PodoCare ORTOMED EC35
by OrtoProfil Prod Romania SRL EUDAMED
Active
Ref 4T.S-200-EC-35
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5944784ORTMEMBRUINFOCSPKV | Date22 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Orteză corectoare de statică a piciorului
- Model / Reference
- 4T.S-200-EC-35
- Primary DI / UDI-DI
- 05944784001486
- Basic UDI-DI
- 5944784ORTMEMBRUINFOCSPKV
- Direct Marketing DI
- 05944784001486
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- RO-MF-000000526
Other devices from OrtoProfil Prod Romania SRL
Properties
Show 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