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Auto Hematology Analyzer

by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref XQ-0110-12Model DH-860CS, DH-870、DH-860、DH-850、DH-820、DH-800[H6]、DH-800[H7]、DH-800[T6]CRP、DH-800[T7]CRP、DH-800[T6]CS、DH-800[T7]CS、DH-870CRP、DH-870CS、DH-860CRP、DH-860CS、DH-850CRP、DH-850CS、DH-820CRP、DH-820CS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06941377306149 Basic UDI-DIDate2 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  • Withdrawn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
DH-860CS, XQ-0110-12, DH-870、DH-860、DH-850、DH-820、DH-800[H6]、DH-800[H7]、DH-800[T6]CRP、DH-800[T7]CRP、DH-800[T6]CS、DH-800[T7]CS、DH-870CRP、DH-870CS、DH-860CRP、DH-860CS、DH-850CRP、DH-850CS、DH-820CRP、DH-820CS
Primary DI / UDI-DI
06941377306149
Basic UDI-DI
B-06941377306149, 697049309W02023012007CS
Direct Marketing DI
06941377306149
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class IVD General
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Shenzhen Dymind Biotechnology Co., Ltd.

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Properties

  • 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