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Blood Gas & Electrolyte Analyzer

by Meizhou Cornley Hi-Tech Co., Ltd. 7 variants

Ref Gaslite80AQModel Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDR Number69479295Gaslite80Z2 Basic UDI-DI 06947929500485UDI-DIDate13 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Blood Gas & Electrolyte Analyzer
Model / Reference
Gaslite80A、Gaslite80B、Gaslite80、Gaslite80AQ、Gaslite80BQ、Gaslite80Q、Gaslite80E, Gaslite80AQ
Primary DI / UDI-DI
06947929500485
Basic UDI-DI
69479295Gaslite80Z2
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
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025014
Authorised representative
Caretechion GmbH DE-AR-000005946

Other devices from Meizhou Cornley Hi-Tech Co., Ltd.

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No