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Intelligent Hematology Analyzer

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref BCI001EU02Model Hemovision Genie 5 Plus

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300121 Basic UDI-DIDate22 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
Hemovision Genie 5 Plus, BCI001EU02
Primary DI / UDI-DI
06976968300121
Basic UDI-DI
B-06976968300121
EMDN Code
W0202010202 Semi-automated hematology analysers
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Shenzhen Channel Biotechnology Co., Ltd.

See all devices from Shenzhen Channel Biotechnology Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (8)

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