Xtern Classic+ Foot Drop Orthotic Size Small
by Turbomed Orthotics inc. EUDAMED
Active
Ref 101155-SA-S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62055328101155HQ | Date16 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Xtern Classic+ Foot Drop Orthotic
- Model / Reference
- 101155-SA-S
- Primary DI / UDI-DI
- 00620553281758, 00628464680028
- Basic UDI-DI
- 62055328101155HQ, 62846468101155VZ
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- 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
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