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Figulla Flex II ASD Occluder Procedure Pack

by Occlutech GmbH 40 variants

Ref 29ASD40F

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426018252ASDIIFLEXIIF6 Basic UDI-DI Date18 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
29ASD40F
Primary DI / UDI-DI
04255888902618, 04260182526521
Basic UDI-DI
426018252ASDIIFLEXIIF6
EMDN Code
P07040302 Cardiac occluders, atrial septal defects
Device Class
Class III
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.

Manufacturer details

EUDAMED SRN
DE-PR-000049872

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Properties

Other properties (1)

  • Sterile: No