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Auto Hematology Analyzer

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref XQ-0001-01Model DH31, DH36 EMDN W0202010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06970493097143 Basic UDI-DIDate30 Mar 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06970493097143 Basic UDI-DIDate30 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
DH31, XQ-0001-01, DH36
Primary DI / UDI-DI
06970493097143
Basic UDI-DI
B-06970493097143, 6970493090608001PL
Direct Marketing DI
06970493097143
EMDN Code
W0202010201 Automated 3 part hematology analysers
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.

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

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 c3b9ab11-4611-4e18-ab70-52e77bbd8241 61 fields · synced 24 Oct 2026
  • EUDAMED 06970493097143|6970493090608001PL 61 fields · synced 15 Oct 2026