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Figulla Flex II ASD

by Occlutech GmbH 20 variants

Ref 29ASD21

Active European Union

CE MDR CE MDD

Valid until

6 May 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DEKRA Certification GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number51030-61-D0-00 Date7 May 2026IssuedStatusActive expires 6 May 2031
European UnionCE/MDD NumberB-04260182520703 Basic UDI-DI Date21 Mar 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

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

    Technical documentation EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    7 May 2026
    Expires
    6 May 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
29ASD21
Primary DI / UDI-DI
04260182520703, 04260182522004
Basic UDI-DI
B-04260182520703, 426018252ASDFlexIIMJ
EMDN Code
P07040302 Cardiac occluders, atrial septal defects
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005104

Other devices from Occlutech GmbH

See all devices from Occlutech GmbH →

Properties

  • 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