Skip to content

Figulla Flex II PFO Occluder Procedure Pack

by Occlutech GmbH Germany EUDAMED

Ref 19PFO25DP EMDN P07040303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426018252PFOIIIPPTB Basic UDI-DIDate9 Jan 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  • Withdrawn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
19PFO25DP
Primary DI / UDI-DI
04255888900478
Basic UDI-DI
426018252PFOIIIPPTB
EMDN Code
P07040303 Cardiac occluders, foramen ovale and botallo duct
Device Class
Class III
Medical Purpose
The Figulla Flex II PFO Occluder is a permanent cardiac implant intended to close a Patent Foramen Ovale.

Manufacturer details

EUDAMED SRN
DE-PR-000049872

Other devices from Occlutech GmbH

See all devices from Occlutech GmbH →

Properties & raw data

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

Sources (1)

  • EUDAMED 3ae55b85-97b2-41a5-9b46-7b78ae79fb96 61 fields · synced 24 Oct 2026