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Figulla Flex II ASD

by Occlutech GmbH Germany EUDAMED

Ref 29ASD18

EMDN P07040302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-04260182520697 Basic UDI-DIDate21 Mar 2025RegisteredStatusActive
European UnionCE/MDD NumberB-04260182520697 Basic UDI-DIDate21 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 51030-61-D0-00 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0124
    Issued
    7 May 2026
    Expires
    6 May 2031

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
29ASD18
Primary DI / UDI-DI
04260182520697, 04260182521984
Basic UDI-DI
B-04260182520697, 426018252ASDFlexIIMJ
EMDN Code
P07040302 Cardiac occluders, atrial septal defects
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005104

Other devices from Occlutech GmbH

See all devices from Occlutech GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 2dbc5125-92cd-4bee-aa8d-e5f719cb7de0 61 fields · synced 23 Oct 2026
  • EUDAMED 04260182521984|426018252ASDFLEXIIMJ 61 fields · synced 24 Oct 2026