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Automated Hematology Analyzer

by Hunan Ehome Health Technology Co., Ltd. EUDAMED

Active European Union

Ref O-Cyte 1Model O-Cyte 1, O-Cyte 2, O-Cyte 3, O-Cyte 4, O-Cyte 5, O-Cyte 6, O-Cyte 7, O-Cyte 8, O-Cyte 9

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975679490640 Basic UDI-DIDate18 May 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  • Withdrawn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
O-Cyte 1, O-Cyte 2, O-Cyte 3, O-Cyte 4, O-Cyte 5, O-Cyte 6, O-Cyte 7, O-Cyte 8, O-Cyte 9
Primary DI / UDI-DI
06975679490640
Basic UDI-DI
B-06975679490640
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000045177
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hunan Ehome Health Technology Co., Ltd.

See all devices from Hunan Ehome Health Technology 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