Identity
- Trade Name
- Figulla Flex II UNI EUDAMED
- Device Name
- Figulla Flex II UNI EUDAMED
- Model / Reference
- 16UNI33 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182520819 EUDAMED
- Basic UDI-DI
- B-04260182520819 EUDAMED
- EMDN Code
- P07040302 CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS 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 UNI 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-04260182520819 | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (1)
- EUDAMED 18833de5-8aa6-45d6-94ac-c61d5ce29efa 61 fields · synced Jun 18, 2026