Skip to content

Hematology Control

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref XQ-0092-03Model Model:DM-6DR,Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1, Model:DM-6DR , Specification:3mL（N）×3 EMDN W0103010503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number697049309W01033013001CB Basic UDI-DIDate4 Jul 2026RegisteredStatusActive
European UnionCE/IVDR Number697049309W01033013001CB Basic UDI-DIDate4 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Model:DM-6DR, Specification：3mL（L）×1+3mL（N）×1+ 3mL（H）×1、2mL（L）×1+2mL（N）×1+ 2mL（H）×1, XQ-0092-03, Specification:3mL（N）×3
Primary DI / UDI-DI
06941377307061
Basic UDI-DI
697049309W01033013001CB, B-06941377307061
Direct Marketing DI
06941377307061
EMDN Code
W0103010503 Multilevel blood controls
Device Class
Class B
Class IVD General
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
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 06941377307061|697049309W01033013001CB 61 fields · synced 24 Oct 2026
  • EUDAMED 06941377307061|B-06941377307061 61 fields · synced 24 Oct 2026