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Figulla Flex II PFO Occluder Procedure Pack

by Occlutech GmbH 9 variants

Ref 19PFO18DP

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426018252PFOIIIPPTB Basic UDI-DI 04255888900409UDI-DIDate9 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
19PFO18DP
Primary DI / UDI-DI
04255888900409
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

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Properties

Other properties (1)

  • Sterile: No