FlexiOH
by Jc Orthoheal Private Limited United States EUDAMED
Ref SOS418
EMDN M030599
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8908014765FLXFY | Date27 Jul 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- FlexiOH - Light Cured Polymer Immobilizer
- Model / Reference
- SOS418
- Primary DI / UDI-DI
- 89080147651706
- Basic UDI-DI
- 8908014765FLXFY
- EMDN Code
- M030599 Immobilisation systems and devices - other
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IN-MF-000026318
- Authorised representative
- AF Pharma Service Europe SL ES-AR-000018076
Other devices from Jc Orthoheal Private Limited
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 069db20e-93d6-443d-9f84-35ed30cc13e6