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Occlutech PDA Occluder

by Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti Türkiye EUDAMED

Ref 42PDA15

EMDN P07040303

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-42PDA15EC Basic UDI-DIDate2 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
42PDA15
Primary DI / UDI-DI
D-42PDA15EC
Basic UDI-DI
B-42PDA15EC
EMDN Code
P07040303 Cardiac occluders, foramen ovale and botallo duct
Device Class
Class III
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000014931

Other devices from Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ff7a333f-666b-4353-8040-2ba53306c8dc 61 fields · synced 22 Oct 2026