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Anesthesia machine

by Shenzhen Comen Medical Instruments Co., LTD. China EUDAMED

Ref X6Model X8

EMDN Z1203010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290AX004LQ Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
X8, X6
Primary DI / UDI-DI
06945429061154
Basic UDI-DI
69454290AX004LQ
Direct Marketing DI
06945429061154
EMDN Code
Z1203010101 Anaesthesia devices
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002236
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

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

Sources (1)

  • EUDAMED b0a7bd34-e037-4124-9ed8-308fcdb43a90 61 fields · synced 22 Oct 2026