Occlutech Atrial Flow Regulator
by Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti Türkiye EUDAMED
Ref 65AFR08L, 65AFR10M, 65AFR08M, 65AFR10L EMDN P0799
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-65AFR08LWZ | Date7 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Model / Reference
- 65AFR08L, 65AFR10M, 65AFR08M, 65AFR10L
- Primary DI / UDI-DI
- D-65AFR08LWZ, D-65AFR10MWG, D-65AFR08MX3, D-65AFR10LWE
- Basic UDI-DI
- B-65AFR08LWZ, B-65AFR10MWG, B-65AFR08MX3, B-65AFR10LWE
- EMDN Code
- P0799 Vascular and cardiac prostheses - other
- Device Class
- Class III
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000014931
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (4)
- EUDAMED da0319ad-00f3-43d8-8434-80485553437d
- EUDAMED D-65AFR10MWG|B-65AFR10MWG
- EUDAMED D-65AFR08MX3|B-65AFR08MX3
- EUDAMED D-65AFR10LWE|B-65AFR10LWE