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Figulla Flex II UNI
EUDAMEDClass III (EU MDR)
Ref 16UNI17Ref 16UNI24Ref 16UNI40Ref 16UNI28
Identity
- Trade Name
- Figulla Flex II UNI EUDAMED
- Device Name
- Figulla Flex II UNI EUDAMED
- Model / Reference
- 16UNI17 EUDAMED16UNI24 EUDAMED16UNI40 EUDAMED16UNI28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182520789 EUDAMED04260182520796 EUDAMED04260182520888 EUDAMED04260182520802 EUDAMED
- Basic UDI-DI
- B-04260182520789 EUDAMEDB-04260182520796 EUDAMEDB-04260182520888 EUDAMEDB-04260182520802 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-04260182520789 | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (4)
- EUDAMED 3ac19525-abbb-4acd-9a97-5c6621084887 61 fields · synced Jul 26, 2026
- EUDAMED dc1d699b-9776-4e48-875a-1a8c336d178c 61 fields · synced May 17, 2026
- EUDAMED 46c3b69a-8adf-4ef2-a879-0c02597be59e 61 fields · synced May 18, 2026
- EUDAMED f7f5cafe-90f3-44ef-806d-c99a06d90c9d 61 fields · synced May 18, 2026