Identity
- Trade Name
- Figulla Flex II ASD Occluder EUDAMED
- Device Name
- Figulla Flex II ASD Occluder Procedure Pack EUDAMED
- Model / Reference
- 29ASD04F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175604171 EUDAMED
- Basic UDI-DI
- 73401756ASDIIFLEXIILV EUDAMED
- EMDN Code
- P07040302 CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Figulla Flex II ASD Occluder is a permanent cardiac implant intended to close atrial septal defects of type ostium secundum. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II ASD Occluder by Occlutech International AB — 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 | 73401756ASDIIFLEXIILV | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (1)
- EUDAMED 5c4d2db5-31b5-4f66-a7fd-f0304fb6f8ad 61 fields · synced Jun 18, 2026