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CMO8 Adult PMP Oxygenator with Tubing Pack

by Chalice Medical Ltd

Ref CME90086Model ECMO Tubing Pack including Oxygenator

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50564696TpackECoxG9 Basic UDI-DI 05060912588053UDI-DIDate22 May 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
ECMO Tubing Pack including Oxygenator, CME90086
Primary DI / UDI-DI
05060912588053
Basic UDI-DI
50564696TpackECoxG9
EMDN Code
C03010102 Oxygenator kits
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

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

Other devices from Chalice Medical Ltd

See all devices from Chalice Medical Ltd →

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