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Hematology Calibrator

by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED 11 variants

Active European Union

Ref XQ-0103-03Model Model:DM-CAL-RET ,Specification:3mL×3, Model:DM-CAL-RET,Specification：3mL×1、3mL×2、3mL×3

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06941377306972 Basic UDI-DIDate4 Jul 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06941377306972 Basic UDI-DIDate4 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

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.

Specification

EUDAMED

Model / Reference
Model:DM-CAL-RET, Specification:3mL×3, XQ-0103-03, Specification：3mL×1、3mL×2、3mL×3
Primary DI / UDI-DI
06941377306972
Basic UDI-DI
B-06941377306972, 697049309W01033013002CD
Direct Marketing DI
06941377306972
EMDN Code
W0103010599 Haematology controls - other
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

  • 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