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Figulla Flex II UNI Occluder
EUDAMEDClass III (EU MDR)
Ref 16UNI17FRef 16UNI33PRef 16UNI40PRef 16UNI24P
Identity
- Trade Name
- Figulla Flex II UNI Occluder EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI17F EUDAMED16UNI33P EUDAMED16UNI40P EUDAMED16UNI24P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175604126 EUDAMED07340175603167 EUDAMED07340175603174 EUDAMED07340175603143 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 e0c851f4-bd8e-4a6a-874e-b9e203cb58fc 61 fields · synced Jul 25, 2026
- EUDAMED 55b9ee43-c13f-4632-af73-6a7985b3c629 61 fields · synced May 17, 2026
- EUDAMED cda2d2e2-ce59-469a-b5d9-dfc2f03d70f7 61 fields · synced May 17, 2026
- EUDAMED 497dfa88-16ce-4854-9124-5e7f632300d4 61 fields · synced May 18, 2026