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Figulla Flex II UNI Occluder
EUDAMEDClass III (EU MDR)
Ref 16UNI24FRef 16UNI17PRef 16UNI33FRef 16UNI28F
Identity
- Trade Name
- Figulla Flex II UNI Occluder EUDAMEDFigulla Flex II UNI Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI24F EUDAMED16UNI17P EUDAMED16UNI33F EUDAMED16UNI28F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175604133 EUDAMED07340175603136 EUDAMED07340175604157 EUDAMED07340175600326 EUDAMED
- Basic UDI-DI
- 73401756UNIIIFLEXII7E EUDAMED73401756UNIIIPPWR EUDAMED
- EMDN Code
- P07040302 CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Figulla Flex II UNI Occluder is a permanent cardiac implant intended to close defects of type multi-fenestrated atrial septal defects. EUDAMEDThe Figulla Flex II UNI Occluder is a permanent cardiac implant intended to close defects of type multi-fenestrated atrial septal defects. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II UNI Occluder by Occlutech International AB — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73401756UNIIIFLEXII7E | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (4)
- EUDAMED c1647d04-2e68-4612-96b8-633b9786ce25 61 fields · synced Jul 24, 2026
- EUDAMED 6e2fc0db-9b9b-40b6-b2c0-bc0b4311c5fd 61 fields · synced May 17, 2026
- EUDAMED 04093fb2-37ef-4b88-ab2d-450c97cdda1f 61 fields · synced May 17, 2026
- EUDAMED 75c89095-b5a3-454d-ab97-8d1fb32294c0 61 fields · synced May 19, 2026