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Figulla Flex II PFO Occluder Procedure Pack

by Occlutech International AB FDA registration: Sweden EUDAMED

Ref 19PFO18DP EMDN P07040303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73401756PFOIIPPSW Basic UDI-DIDate18 Mar 2025RegisteredStatusActive

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  • Withdrawn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 23 Oct 2026

Model / Reference
19PFO18DP
Primary DI / UDI-DI
07340175604089, 07340175600067
Basic UDI-DI
73401756PFOIIPPSW
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
SE-PR-000017759

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Properties & raw data

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

Sources (2)

  • EUDAMED f5d79aad-2dd9-43ca-9a98-d445a6808a46 61 fields · synced 23 Oct 2026
  • EUDAMED 07340175600067|73401756PFOIIPPSW 61 fields · synced 19 May 2026