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Figulla Flex II UNI Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 16UNI40FRef 16UNI28PRef 16UNI33FRef 16UNI17FRef 16UNI33PRef 16UNI40PRef 16UNI24F
Identity
- Trade Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II UNI Occluder Procedure Pack EUDAMED
- Model / Reference
- 16UNI40F EUDAMED16UNI28P EUDAMED16UNI33F EUDAMED16UNI17F EUDAMED16UNI33P EUDAMED16UNI40P EUDAMED16UNI24F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175600340 EUDAMED07340175600029 EUDAMED07340175600333 EUDAMED07340175600302 EUDAMED07340175600036 EUDAMED07340175600043 EUDAMED07340175600319 EUDAMED
- Basic UDI-DI
- 73401756UNIIIFLEXII7E EUDAMED73401756UNIIIPPWR EUDAMED
- EMDN Code
- P07040302 CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Figulla Flex II UNI Occluder is a permanent cardiac implant intended to close defects of type multi-fenestrated atrial septal defects. EUDAMEDThe Figulla Flex II UNI Occluder is a permanent cardiac implant intended to close defects of type multi-fenestrated atrial septal defects. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II UNI Occluder Procedure Pack 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 | 73401756UNIIIFLEXII7E | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (7)
- EUDAMED b32bd922-6975-42e2-b0a3-5bb96103f54e 61 fields · synced Jul 18, 2026
- EUDAMED 168a8f2d-3ea3-4f88-928e-9adaa5207c28 61 fields · synced May 17, 2026
- EUDAMED 2d7e0444-9fc7-42ef-9fb5-f79a9a5f6e6b 61 fields · synced May 17, 2026
- EUDAMED 9f343239-b9eb-40ca-b0de-2c383fc4edfc 61 fields · synced May 17, 2026
- EUDAMED d73c3ac6-e8c2-4010-acbc-a5fe5b167ed4 61 fields · synced May 17, 2026
- EUDAMED 3aeb81ae-fef0-46e5-be48-60c0149111f3 61 fields · synced May 19, 2026
- EUDAMED b3707f0e-120c-431a-979d-78b1f8830a0b 61 fields · synced May 19, 2026