Skip to content

Hematology Calibrator

by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref XQ-0009-03Model DM-CAL-PF

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6970493090608031PV Basic UDI-DIDate11 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
DM-CAL-PF, XQ-0009-03
Primary DI / UDI-DI
06976117451919
Basic UDI-DI
6970493090608031PV
Direct Marketing DI
06976117451919
EMDN Code
W0103010507 Whole blood calibrators
Device Class
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

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No