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Figulla Flex II PFO Occluder Procedure Pack
EUDAMEDClass III (EU MDR)
Ref 19PFO35DFRef 19PFO25DFRef 19PFO35DPRef 19PFO30DFRef 19PFO25DPRef 19PFO18DPRef 18PFO25SPRef 18PFO25SFRef 19PFO18DF
Identity
- Trade Name
- Figulla Flex II PFO Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II PFO Occluder Procedure Pack EUDAMED
- Model / Reference
- 19PFO35DF EUDAMED19PFO25DF EUDAMED19PFO35DP EUDAMED19PFO30DF EUDAMED19PFO25DP EUDAMED19PFO18DP EUDAMED18PFO25SP EUDAMED18PFO25SF EUDAMED19PFO18DF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340175604782 EUDAMED07340175604768 EUDAMED07340175600098 EUDAMED07340175604775 EUDAMED07340175604096 EUDAMED07340175604089 EUDAMED07340175604072 EUDAMED07340175600388 EUDAMED07340175600050 EUDAMED07340175604744 EUDAMED07340175604751 EUDAMED
- Basic UDI-DI
- 73401756PFOIIFLEXIIXJ EUDAMED73401756PFOIIPPSW EUDAMED
- EMDN Code
- P07040303 CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Medical Purpose
- The Figulla Flex II PFO Occluder is a permanent cardiac implant intended to close a Patent Foramen Ovale. EUDAMEDThe Figulla Flex II PFO Occluder is a permanent cardiac implant intended to close a Patent Foramen Ovale. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Figulla Flex II PFO 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 | 73401756PFOIIFLEXIIXJ | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech International AB
- EUDAMED SRN
- SE-PR-000017759
Sources (11)
- EUDAMED edaaf06a-0ddd-4d28-86d6-e1a0c7d652dc 61 fields · synced Aug 1, 2026
- EUDAMED 6e472ddc-0be1-436a-85b4-5094ffe320ab 61 fields · synced May 17, 2026
- EUDAMED 0daf6e86-f168-4996-b5a9-c9d7586961dd 61 fields · synced May 17, 2026
- EUDAMED e81251f5-c2e3-47eb-9c87-82b2c1a24437 61 fields · synced May 17, 2026
- EUDAMED 877b5662-9d4d-4182-98f0-ff47aee426b6 61 fields · synced May 17, 2026
- EUDAMED f5d79aad-2dd9-43ca-9a98-d445a6808a46 61 fields · synced May 17, 2026
- EUDAMED 509813d1-ada8-4c55-86ca-65b38d89f816 61 fields · synced May 17, 2026
- EUDAMED 701e970d-4264-4d48-8607-b3ed015641c5 61 fields · synced May 19, 2026
- EUDAMED e7847bdf-1b52-4e01-8d85-d72385a68744 61 fields · synced May 19, 2026
- EUDAMED 0e58e0c7-74ae-43e7-9e06-dc3da6fde74e 61 fields · synced May 19, 2026
- EUDAMED ed3822b9-a07d-40b0-90e9-4bbb36c1a5a1 61 fields · synced May 19, 2026