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WBC Analyzer

by Diasia Biomedical Technology Co., Ltd. China EUDAMED

Ref A411011Model Speedry WBC

EMDN W0202010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697331674WBC00000QR Basic UDI-DIDate5 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
WBC Analyzer
Model / Reference
Speedry WBC, A411011
Primary DI / UDI-DI
06973316740257
Basic UDI-DI
697331674WBC00000QR
EMDN Code
W0202010299 Limited panel cell counting analysers - other
Device Class
Class A
Market of Registration
Austria

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
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED a66ddf27-6bde-410d-b19f-ca5fb6307a1a 61 fields · synced 22 Oct 2026