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Automatic Hematology Analyzer

by Changsha Han Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref 041Model iMC Ge52e

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697721610020010002DR Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
iMC Ge52e, 041
Primary DI / UDI-DI
06977216100418
Basic UDI-DI
697721610020010002DR
Direct Marketing DI
06977216100418
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000042919
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Changsha Han Biotechnology Co., Ltd.

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