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Hematology Calibrator

by Shenzhen Dymind Biotechnology Co., Ltd. China EUDAMED

Ref XQ-0103-02Model Model:DM-CAL-RET,Specification：3mL×1、3mL×2、3mL×3, Model:DM-CAL-RET ,Specification:3mL×2 EMDN W0103010599

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number697049309W01033013002CD Basic UDI-DIDate4 Jul 2026RegisteredStatusActive
European UnionCE/IVDR Number697049309W01033013002CD 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  • Withdrawn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-CAL-RET, Specification：3mL×1、3mL×2、3mL×3, XQ-0103-02, Specification:3mL×2
Primary DI / UDI-DI
06941377306965
Basic UDI-DI
697049309W01033013002CD, B-06941377306965
Direct Marketing DI
06941377306965
EMDN Code
W0103010599 Haematology controls - other
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 06941377306965|697049309W01033013002CD 61 fields · synced 24 Oct 2026
  • EUDAMED 06941377306965|B-06941377306965 61 fields · synced 24 Oct 2026