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Figulla Flex II UNI Occluder

by Occlutech International AB 7 variants

Ref 16UNI24P

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 Number73401756UNIIIPPWR Basic UDI-DI 07340175603143UDI-DIDate19 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  • Withdrawn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

Device Name
Figulla Flex II UNI Occluder Procedure Pack
Model / Reference
16UNI24P
Primary DI / UDI-DI
07340175603143
Basic UDI-DI
73401756UNIIIPPWR
EMDN Code
P07040302 Cardiac occluders, atrial septal defects
Device Class
Class III
Medical Purpose
The Figulla Flex II UNI Occluder is a permanent cardiac implant intended to close defects of type multi-fenestrated atrial septal defects.

Manufacturer details

EUDAMED SRN
SE-PR-000017759

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Properties

Other properties (1)

  • Sterile: No