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Auto Hematology Analyzer

by Shenzhen Dymind Biotechnology Co., Ltd. 59 variants

Ref XQ-0042-05Model DH-800[T7]CS, 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

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06976117452688 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06976117452688 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
DH-800[T7]CS, XQ-0042-05, 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
06976117452688
Basic UDI-DI
B-06976117452688, 697049309W02023012007CS
Direct Marketing DI
06976117452688
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