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Auto Hematology Analyzer

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref Hemaray 86

EMDN W0202010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-Hemaray86FV Basic UDI-DIDate29 May 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-Hemaray86FV Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Hemaray 86
Primary DI / UDI-DI
D-Hemaray86FV, 06947024409744
Basic UDI-DI
B-Hemaray86FV, 69470244006355V
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class IVD General
Class B
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED ee5eee8d-6fd8-47a1-bcec-aef3dd96c8d1 61 fields · synced 22 Oct 2026
  • EUDAMED 06947024409744|69470244006355V 61 fields · synced 22 Oct 2026