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Flow Cytometer

by Beijing Challen Biotechnology Co., Ltd. China EUDAMED

Ref C.LS.A2000S2

EMDN W0202040103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697530920G521E4 Basic UDI-DIDate20 May 2026RegisteredStatusActive

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
C.LS.A2000S2
Primary DI / UDI-DI
06975309200656
Basic UDI-DI
697530920G521E4
Direct Marketing DI
06975309200656
EMDN Code
W0202040103 Cytoflowmeters - high routine
Device Class
Class A
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000023656
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Beijing Challen Biotechnology Co., Ltd.

See all devices from Beijing Challen Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED d3e8dc9b-c810-4180-8104-28ebce3ae0d4 61 fields · synced 22 Oct 2026