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Figulla Flex II ASD
EUDAMEDClass III (EU MDR)
Ref 29ASD06Ref 29ASD09FRef 29ASD15PRef 29ASD05FRef 29ASD13FRef 29ASD21Ref 29ASD36PRef 29ASD13Ref 29ASD15FRef 29ASD07FRef 29ASD10PRef 29ASD18PRef 29ASD33Ref 29ASD33PRef 29ASD30FRef 29ASD19FRef 29ASD27FRef 29ASD27PRef 29ASD39Ref 29ASD36FRef 29ASD40PRef 29ASD10FRef 29ASD12Ref 29ASD05Ref 29ASD18Ref 29ASD40FRef 29ASD09PRef 29ASD33FRef 29ASD06FRef 29ASD18FRef 29ASD24FRef 29ASD16PRef 29ASD12PRef 29ASD04F
Identity
- Trade Name
- Figulla Flex II ASD EUDAMEDFigulla Flex II ASD Occluder Procedure Pack EUDAMED
- Device Name
- Figulla Flex II ASD EUDAMEDFigulla Flex II ASD Occluder Procedure Pack EUDAMED
- Model / Reference
- 29ASD06 EUDAMED29ASD09F EUDAMED29ASD15P EUDAMED29ASD05F EUDAMED29ASD13F EUDAMED29ASD21 EUDAMED29ASD36P EUDAMED29ASD13 EUDAMED29ASD15F EUDAMED29ASD07F EUDAMED29ASD10P EUDAMED29ASD18P EUDAMED29ASD33 EUDAMED29ASD33P EUDAMED29ASD30F EUDAMED29ASD19F EUDAMED29ASD27F EUDAMED29ASD27P EUDAMED29ASD39 EUDAMED29ASD36F EUDAMED29ASD40P EUDAMED29ASD10F EUDAMED29ASD12 EUDAMED29ASD05 EUDAMED29ASD18 EUDAMED29ASD40F EUDAMED29ASD09P EUDAMED29ASD33F EUDAMED29ASD06F EUDAMED29ASD18F EUDAMED29ASD24F EUDAMED29ASD16P EUDAMED29ASD12P EUDAMED29ASD04F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260182520635 EUDAMED04255888901413 EUDAMED04255888901765 EUDAMED04255888901178 EUDAMED04255888901659 EUDAMED04260182520703 EUDAMED04255888902489 EUDAMED04260182520864 EUDAMED04255888901734 EUDAMED04255888901338 EUDAMED04255888901529 EUDAMED04255888901925 EUDAMED04260182520741 EUDAMED04255888902403 EUDAMED04255888902298 EUDAMED04255888901970 EUDAMED04255888902212 EUDAMED04255888902243 EUDAMED04260182520765 EUDAMED04255888902458 EUDAMED04255888902649 EUDAMED04255888901499 EUDAMED04260182520673 EUDAMED04260182520628 EUDAMED04260182520697 EUDAMED04255888902618 EUDAMED04255888901444 EUDAMED04255888902373 EUDAMED04255888901253 EUDAMED04255888901895 EUDAMED04255888902137 EUDAMED04255888901840 EUDAMED04255888901604 EUDAMED04255888901086 EUDAMED
- Basic UDI-DI
- B-04260182520635 EUDAMED426018252ASDIIFLEXIIF6 EUDAMED426018252ASDIIPP9A EUDAMEDB-04260182520703 EUDAMEDB-04260182520864 EUDAMEDB-04260182520741 EUDAMEDB-04260182520765 EUDAMEDB-04260182520673 EUDAMEDB-04260182520628 EUDAMEDB-04260182520697 EUDAMED
- EMDN Code
- P07040302 CARDIAC OCCLUDERS, ATRIAL SEPTAL DEFECTS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- The Figulla Flex II ASD Occluder is a permanent cardiac implant intended to be delivered by a percutaneous, transcatheter procedure and to close atrial septal defects of type ostium secundum. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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 ASD by Occlutech GmbH — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260182520635 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04260182520635 | Class III | Active |
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Manufacturer
- Manufacturer
- Occlutech GmbH
- EUDAMED SRN
- DE-MF-000005104
Sources (34)
- EUDAMED 6ae29c90-6252-4160-a90b-a27bbf106782 61 fields · synced Sep 18, 2026
- EUDAMED 1a029f8f-a34b-49cd-bb07-435afc7c7ca1 61 fields · synced May 11, 2026
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- EUDAMED 96105f23-a57e-4b3f-9f31-2ca093ec7946 61 fields · synced May 16, 2026
- EUDAMED a13efcf6-23c1-4566-8729-05a963732074 61 fields · synced May 17, 2026
- EUDAMED 0eb4a44f-f1d9-4d3e-8f79-cab055184018 61 fields · synced May 17, 2026
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- EUDAMED bed5d177-1647-49c9-9ee6-811794737ec3 61 fields · synced May 18, 2026
- EUDAMED cb869411-c154-4e0c-97a6-3bb2884201a1 61 fields · synced May 18, 2026
- EUDAMED ccdb6709-6894-4901-be2d-abfeaf194423 61 fields · synced May 18, 2026
- EUDAMED 27d9aaf5-56ca-4e6c-98db-3f8738b1ae93 61 fields · synced May 19, 2026
- EUDAMED 4ed23b8d-4ddc-4d53-a701-5aa60fa01834 61 fields · synced May 19, 2026
- EUDAMED 7a800224-ef8d-44fc-b641-0d9fc1f3194a 61 fields · synced May 19, 2026
- EUDAMED 2dbc5125-92cd-4bee-aa8d-e5f719cb7de0 61 fields · synced May 19, 2026
- EUDAMED 984109fa-8098-420d-bc13-e8d8cafae166 61 fields · synced May 19, 2026
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- EUDAMED 593d70d9-ecca-45b6-aaee-88dba92aa95a 61 fields · synced May 19, 2026
- EUDAMED 8b91d6da-0987-44fe-8143-190021051083 61 fields · synced May 19, 2026
- EUDAMED 6ef23f27-ef80-45f6-9ed5-bf4b9fcbcb28 61 fields · synced May 19, 2026
- EUDAMED 6c16be80-bb70-49f5-b6e8-72dc824810fe 61 fields · synced May 19, 2026
- EUDAMED baedef37-16fb-492a-a0b2-b541aa1195dc 61 fields · synced May 19, 2026
- EUDAMED 88c9cb08-01f3-4336-8e61-53e526967a8e 61 fields · synced May 19, 2026