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Figulla Flex II PFO Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 19PFO30DF
Identity
- Trade Name
- Figulla Flex II PFO Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II PFO Occluder Procedure Pack EUDAMED
- Model / Reference
- 19PFO30DF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888900522 EUDAMED
- Basic UDI-DI
- 426018252PFOIIIFLEXIIRS EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Figulla Flex II PFO Occluder is a permanent cardiac implant intended to close a Patent Foramen Ovale. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II PFO 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 | 426018252PFOIIIFLEXIIRS | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED f7d868a8-4a2b-4fe6-bfb7-499e9c9c48f5 61 fields · synced Jun 18, 2026