Identity
- Trade Name
- Figulla Flex II UNI Occluder EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI40F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175604164 EUDAMED
- Basic UDI-DI
- 73401756UNIIIFLEXII7E 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. 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 (1)
- EUDAMED 36e335d7-6018-4a7a-9c02-2382b574cfd8 61 fields · synced Jun 19, 2026