Identity
- Trade Name
- Figulla Flex II PFO EUDAMED
- Device Name
- Figulla Flex II PFO EUDAMED
- Model / Reference
- 18PFO25S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182520567 EUDAMED
- Basic UDI-DI
- B-04260182520567 EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260182520567 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (1)
- EUDAMED 6cba243a-d861-4082-86a3-729584ef5eaf 61 fields · synced Jun 18, 2026