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Product name: Emergency and Transport Ventilator

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

Ref EV2 EMDN Z12030104

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69454290EV003ML Basic UDI-DIDate11 Feb 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Emergency and Transport Ventilator
Model / Reference
EV2
Primary DI / UDI-DI
06945429025064
Basic UDI-DI
69454290EV003ML
Direct Marketing DI
06945429025064
EMDN Code
Z12030104 Portable pulmonary ventilators
Device Class
Class IIb

Manufacturer details

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

Other devices from Shenzhen Comen Medical Instruments Co., LTD.

See all devices from Shenzhen Comen Medical Instruments Co., LTD. →

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 14d6668a-43a8-4ce2-8b41-8cf904246c70 61 fields · synced 24 Oct 2026