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Blood Gas Electrolyte Analyzer

by Shenzhen Cornley Bio-Medical Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref The model number is consistent with the catalogue numberModel Vitagas8E、BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-800Q, BG5000E、BG5000、BG5000B、BG5000A、Vitagas 5E、Vitagas 5 Vitagas 5B、Vitagas 5A

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697287382Vitagas8EB6 Basic UDI-DIDate11 May 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Vitagas8E、BG-800A、BG-800B、BG-800、BG-800AQ、BG-800BQ、BG-800Q, The model number is consistent with the catalogue number, BG5000E、BG5000、BG5000B、BG5000A、Vitagas 5E、Vitagas 5 Vitagas 5B、Vitagas 5A
Primary DI / UDI-DI
06972873820075, 06972873820051, 06972873821829, 06972873821843, 06972873822529
Basic UDI-DI
697287382Vitagas8EB6, 697287382BG5000EF8
Direct Marketing DI
06972873820075
06972873820051
06972873821829
06972873821843
06972873822529
EMDN Code
W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000017322
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Cornley Bio-Medical Co., Ltd.

Properties

Show properties
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No