Xtern Classic Foot Drop Orthotic, Size Pediatric
Ref 100100-SA-P
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62055328100100GQ 00620553280911 | Date16 Jan 2025 | StatusActive |
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- Withdrawn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
- Device Name
- Xtern Classic Foot Drop Orthotic
- Model / Reference
- 100100-SA-P
- Primary DI / UDI-DI
- 00620553280911
- Basic UDI-DI
- 62055328100100GQ
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CA-MF-000032108
- Authorised representative
- OKO SOLUTION FR-AR-000006781
Other devices from Turbomed Orthotics inc.
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