Flexsoft
Ref FL11DModel FLEXSOFT
Flexsoft (FL11D) is a Class I device made by Orthosoft, registered in EUDAMED on 13 Apr 2022 (Basic UDI-DI 37602703434010449376H), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number37602703434010449376H 03760270340271 | Date13 Apr 2022 | StatusActive |
Official records
- EUDAMED public site 37602703434010449376H
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- FLEXSOFT, FL11D
- Primary DI / UDI-DI
- 03760270340271
- Basic UDI-DI
- 37602703434010449376H
- EMDN code
- Y060612 Wrist-hand orthoses
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000216
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