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Figulla Flex II ASD Occluder Procedure Pack

by Occlutech GmbH Germany EUDAMED

Ref 29ASD13F EMDN P07040302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426018252ASDIIFLEXIIF6 Basic UDI-DIDate18 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
29ASD13F
Primary DI / UDI-DI
04255888901659, 04260182526408
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 & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (2)

  • EUDAMED 6081563b-f749-41de-8eae-7511be58f3ee 61 fields · synced 24 Oct 2026
  • EUDAMED 04260182526408|426018252ASDIIFLEXIIF6 61 fields · synced 24 Oct 2026