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Occlutech Paravalvular Leak Device Procedure Pack

by Occlutech GmbH 38 variants

Ref 61PLD08WF

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 Number426018252PLDFLEXIRC Basic UDI-DI 04260182523414UDI-DIDate17 Mar 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  • Withdrawn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
61PLD08WF
Primary DI / UDI-DI
04260182523414
Basic UDI-DI
426018252PLDFLEXIRC
EMDN Code
P07040399 Heart and coronary defect occluders - other
Device Class
Class III
Medical Purpose
The Occlutech PLD Occluder is a closure device. It is intended for closure of paravalvular leak and is implanted via percutaneous catheter interventional procedure.

Manufacturer details

EUDAMED SRN
DE-PR-000049872

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Properties

Other properties (1)

  • Sterile: No