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Figulla Flex II UNI Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 16UNI17P
Identity
- Trade Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI17P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888900034 EUDAMED
- Basic UDI-DI
- 426018252UNIIIPPKL 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 multifenestrated atrial septal defects. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II UNI Occluder Procedure Pack by Occlutech GmbH — 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 | 426018252UNIIIPPKL | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 03ab7cfc-50af-4c05-831a-b38d756b0885 61 fields · synced Jun 18, 2026