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WBC Colour Agent

by Diasia Biomedical Technology Co., Ltd. China EUDAMED

Ref R631012 EMDN W01030708

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697331674R63101000EL Basic UDI-DIDate5 Dec 2025RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
WBC Colour Agent
Model / Reference
R631012
Primary DI / UDI-DI
06973316743616
Basic UDI-DI
697331674R63101000EL
EMDN Code
W01030708 Stain solutions (histology/cytology)
Device Class
Class A
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED c3305b19-7a89-4f43-a347-60bf2058dbe3 61 fields · synced 22 Oct 2026