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Blood Gas Electrolyte Analyzer

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

Ref Vitagas 5E, 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, BG5000F 、Vitagas5F, BG9000 EMDN W0201040102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06972873820235 Basic UDI-DIDate6 Sep 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-06972873820235 Basic UDI-DIDate6 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Vitagas 5E, 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, BG5000F 、Vitagas5F, BG9000
Primary DI / UDI-DI
06972873820235, 06972873820020, 06972873820082, 06972873820044, 06972873820068, 06972873822505, 06972873822697, 06972873821812, 06972873822536, 06972873820013, 06972873822512, 06972873822703, 06972873822499, 06972873821836
Basic UDI-DI
B-06972873820235, 697287382Vitagas8EB6, 697287382BG5000EF8, 697287382BGV5FPM, 697287382BG9000EJ
Direct Marketing DI
06972873820020
06972873820082
06972873820044
06972873820068
06972873822505
06972873822697
06972873821812
06972873822536
06972873820013
06972873822512
06972873822703
06972873822499
06972873821836
EMDN Code
W0201040102 BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)
Device Class
Class IVD General
Class A
Market of Registration
Netherlands

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 & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • 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

Sources (14)

  • EUDAMED 4cebcd68-a7ae-4687-bf74-93fe6f6b45ba 61 fields · synced 24 Oct 2026
  • EUDAMED 06972873820020|697287382VITAGAS8EB6 61 fields · synced 18 Jun 2026
  • EUDAMED 06972873820082|697287382VITAGAS8EB6 61 fields · synced 18 Jun 2026
  • EUDAMED 06972873820044|697287382VITAGAS8EB6 61 fields · synced 9 Jul 2026
  • EUDAMED 06972873820068|697287382VITAGAS8EB6 61 fields · synced 9 Jul 2026
  • EUDAMED 06972873822505|697287382BG5000EF8 61 fields · synced 13 Jul 2026
  • EUDAMED 06972873822697|697287382BGV5FPM 61 fields · synced 15 Jul 2026
  • EUDAMED 06972873821812|697287382BG5000EF8 61 fields · synced 17 Jul 2026
  • EUDAMED 06972873822536|697287382BG9000EJ 61 fields · synced 20 Jul 2026
  • EUDAMED 06972873820013|697287382VITAGAS8EB6 61 fields · synced 24 Jul 2026
  • EUDAMED 06972873822512|697287382BG5000EF8 61 fields · synced 28 Jul 2026
  • EUDAMED 06972873822703|697287382BGV5FPM 61 fields · synced 2 Aug 2026
  • EUDAMED 06972873822499|697287382BG5000EF8 61 fields · synced 5 Oct 2026
  • EUDAMED 06972873821836|697287382BG5000EF8 61 fields · synced 9 Oct 2026