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Occlutech PDA Occluder Procedure Pack

by Occlutech International AB FDA registration: Sweden EUDAMED

Ref 42PDA15O EMDN P07040303

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number73401756PDAOOPJP Basic UDI-DIDate21 Mar 2025RegisteredStatusActive

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  • Withdrawn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
42PDA15O
Primary DI / UDI-DI
07340175600661, 07340175605055
Basic UDI-DI
73401756PDAOOPJP
EMDN Code
P07040303 Cardiac occluders, foramen ovale and botallo duct
Device Class
Class III
Medical Purpose
The Occlutech PDA Occluder is a percutaneous transcatheter medical device for the non-surgical closure of Patent Ductus Arteriosus (PDA).

Manufacturer details

EUDAMED SRN
SE-PR-000017759

Other devices from Occlutech International AB

See all devices from Occlutech International AB →

Properties & raw data

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

Sources (2)

  • EUDAMED c87d3d4e-3a75-4de9-b62b-520ef2a1ad85 61 fields · synced 23 Oct 2026
  • EUDAMED 07340175605055|73401756PDAOOPJP 61 fields · synced 17 May 2026