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Extracorporeal Circulation Kit

by Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Türkiye EUDAMED

Ref 958 383838 001 EMDN C03010101

Overview

The Extracorporeal Circulation Kit is a high-quality medical device designed for administering cardiopulmonary bypass, providing a safe and efficient solution for patients undergoing cardiac surgery. Featuring advanced technology and robust safety features, this device ensures the highest level of patient care.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86810495TF-08NS Basic UDI-DIDate13 Mar 2023RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
958 383838 001
Primary DI / UDI-DI
08681049565907
Basic UDI-DI
86810495TF-08NS
EMDN Code
C03010101 Extracorporeal circulation circuits
Device Class
Class IIa
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
TR-MF-000018945

Other devices from Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇

See all devices from Di̇sposet Tibbi̇ Ürünler Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 47474eaa-b3ce-481d-afbf-84495c804580 61 fields · synced 22 Oct 2026