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Figulla Flex II PFO Occluder Procedure Pack

by Occlutech International AB 10 variants

Ref 19PFO25DP

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73401756PFOIIPPSW Basic UDI-DI Date18 Mar 2025RegisteredStatusActive

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  • Withdrawn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
19PFO25DP
Primary DI / UDI-DI
07340175604096, 07340175600074
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

Other properties (1)

  • Sterile: No