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SpectroFlo® QC Beads

by Cytek Biosciences Inc. United States EUDAMED

Ref B7-20002

EMDN W0202040185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0850037353QCBEADS5E Basic UDI-DIDate21 Aug 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

Model / Reference
B7-20002
Primary DI / UDI-DI
00850037353613
Basic UDI-DI
0850037353QCBEADS5E
EMDN Code
W0202040185 Cytoflowmeters - consumables
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000032048
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Cytek Biosciences Inc.

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 5780cd76-a93e-4815-b824-951bf0af894e 61 fields · synced 22 Oct 2026