Kösemed
by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.Ş. 1,000+ variants
Ref 108
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 | Number868203550108G4 8682035503972 | Date16 Sep 2026 | 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- Withdrawn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
- Örgü Aşi̇l Tendon Bandi
- Model / Reference
- 108
- Primary DI / UDI-DI
- 8682035503972
- Basic UDI-DI
- 868203550108G4
- Direct Marketing DI
- 8682035503972
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000021022
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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