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Occlutech Paravalvular Leak Device Procedure Pack

by Occlutech GmbH Germany EUDAMED

Ref 63PLD12TF EMDN P07040399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426018252PLDFLEXIRC Basic UDI-DIDate17 Mar 2026RegisteredStatusActive

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  • Withdrawn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
63PLD12TF
Primary DI / UDI-DI
04260182524244
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 & raw data

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

Sources (1)

  • EUDAMED 2ff7f590-fa8a-40fb-b54d-ea513a621caf 61 fields · synced 23 Oct 2026