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Adult ECMO Tubing Pack without Oxy

by Chalice Medical Ltd EUDAMED

Active European Union

Ref CM5740Model ECMO Tubing Pack

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50564696TPackECK3 Basic UDI-DIDate22 May 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  • Withdrawn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

Model / Reference
ECMO Tubing Pack, CM5740
Primary DI / UDI-DI
05060912589692
Basic UDI-DI
50564696TPackECK3
EMDN Code
C03010301 Cardiopulmonary support kits (c.p.s. and ecmo)
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
GB-MF-000010617
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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Properties

Show properties
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No