Ligament Assisted Ankle Support
by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş.
Part of a family of 82 devices: see the family page
Ref 196Model KÖSEMED
Ligament Assisted Ankle Support (196) is a Class I device made by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş., registered in EUDAMED on 4 Dec 2024 (Basic UDI-DI 86820355KOS2000PM), active as of 22 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 | Number86820355KOS2000PM 08682035504023 | Date4 Dec 2024 | StatusActive |
Official records
- EUDAMED public site 86820355KOS2000PM
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- Withdrawn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
- KÖSEMED, 196
- Primary DI / UDI-DI
- 08682035504023
- Basic UDI-DI
- 86820355KOS2000PM
- Direct marketing DI
- 08682035504023
- EMDN code
- Y06120601 Passive ankle-foot orthoses
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000021022
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