← Back to catalogue
Figulla® Flex II PFO Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 18PFO25SP
Identity
- Trade Name
- Figulla® Flex II PFO Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II PFO Occluder Procedure Pack EUDAMED
- Model / Reference
- 18PFO25SP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04255888900331 EUDAMED
- Basic UDI-DI
- 426018252PFOIIIPPTB 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 | 426018252PFOIIIPPTB | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-PR-000049872
Sources (1)
- EUDAMED 1ac3ebd4-0d33-40d8-b457-de61bf47eeac 61 fields · synced Jul 23, 2026