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Blood cell morphology analyzer

by Zhuji Zhiwei Information and Technology Ltd. 2 variants

Ref GCA1027Model MG-G0R-CA1-027, MG-G0R-GA1-027, MG-G0R-HA1-027

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697444212ZWXK.0001.27T3 Basic UDI-DI 06974442120012UDI-DIDate27 Oct 2021RegisteredStatusActive

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  • Withdrawn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 cell morphology analyzer
Model / Reference
MG-G0R-CA1-027, MG-G0R-GA1-027, MG-G0R-HA1-027, GCA1027
Primary DI / UDI-DI
06974442120012
Basic UDI-DI
697444212ZWXK.0001.27T3
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015261
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Zhuji Zhiwei Information and Technology Ltd.

Properties

  • Human Tissues
  • Professional Testing
  • Surgical Instrument

Other properties (8)

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