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Figulla Flex II UNI Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 16UNI33PRef 16UNI40PRef 16UNI24PRef 16UNI40F
Identity
- Trade Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI33P EUDAMED16UNI40P EUDAMED16UNI24P EUDAMED16UNI40F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888900218 EUDAMED04255888900270 EUDAMED04255888900096 EUDAMED04255888900256 EUDAMED
- Basic UDI-DI
- 426018252UNIIIPPKL EUDAMED426018252UNIIIFLEXIIZL 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 (4)
- EUDAMED 5e91f5a7-f316-488b-908c-9c09f6e4c84c 61 fields · synced Jul 26, 2026
- EUDAMED c13993e6-9f37-4d82-878f-ef228f431d19 61 fields · synced May 17, 2026
- EUDAMED 854983c0-b901-4b29-9c48-2b4c8d17c511 61 fields · synced May 19, 2026
- EUDAMED 6eb21bfc-bf36-462e-8a2e-a89c08015d22 61 fields · synced May 19, 2026