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Figulla Flex II PFO
EUDAMEDClass III (EU MDR)
Ref 19PFO25DRef 19PFO30DRef 19PFO25DPRef 19PFO35DRef 19PFO18DP
Identity
- Trade Name
- Figulla Flex II PFO EUDAMEDFigulla Flex II PFO Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II PFO EUDAMEDFigulla Flex II PFO Occluder Procedure Pack EUDAMED
- Model / Reference
- 19PFO25D EUDAMED19PFO30D EUDAMED19PFO25DP EUDAMED19PFO35D EUDAMED19PFO18DP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182520581 EUDAMED04260182520598 EUDAMED04255888900478 EUDAMED04260182520604 EUDAMED04255888900409 EUDAMED
- Basic UDI-DI
- B-04260182520581 EUDAMEDB-04260182520598 EUDAMED426018252PFOIIIPPTB EUDAMEDB-04260182520604 EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMEDEUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Figulla Flex II PFO by Occlutech GmbH — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260182520581 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04260182520581 | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (5)
- EUDAMED 2ba7a40a-f267-4d31-ae14-4978f37f0536 61 fields · synced Aug 3, 2026
- EUDAMED d47bb47a-e004-4ab7-8b54-31247c675460 61 fields · synced May 17, 2026
- EUDAMED 3ae55b85-97b2-41a5-9b46-7b78ae79fb96 61 fields · synced May 17, 2026
- EUDAMED e6895de0-b8a5-4e28-982e-04a4721eabb1 61 fields · synced May 17, 2026
- EUDAMED 3f2d69ee-c95b-4d6f-9f73-d4a8ee6fb80c 61 fields · synced May 19, 2026