Knitted Achilles Tendon Ankle Support
by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. 5 variants
Ref 108-04Model KÖSEMED
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 | Number86820355KOS2000PM 08682035503989 | Date4 Dec 2024 | 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- Withdrawn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
- Model / Reference
- KÖSEMED, 108-04
- Primary DI / UDI-DI
- 08682035503989
- Basic UDI-DI
- 86820355KOS2000PM
- Direct Marketing DI
- 08682035503989
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000021022
Other devices from Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş.
See all devices from Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. →
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