Identity
- Trade Name
- Kösemed EUDAMED
- Device Name
- Silikon Tabanlık 3/4 M EUDAMED
- Model / Reference
- 624-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-86820355002925L EUDAMED
- Basic UDI-DI
- B-86820355002925L EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthotic insole, prefabricated, non-antimicrobial
Kösemed by Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.ş. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-86820355002925L | Class I | Active |
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Manufacturer
- Manufacturer
- Kösemed Ortopedi̇ San. Ve Ti̇c. İth. İhr. A.ş.
- EUDAMED SRN
- TR-MF-000021022
Sources (1)
- EUDAMED 9b466829-1926-47e6-b62b-4adac24e61a3 61 fields · synced Jun 19, 2026