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Flow Cytometer

by Beijing Challen Biotechnology Co., Ltd. China EUDAMED

Ref LongCyte C3111

EMDN W0202040103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697530920026JM Basic UDI-DIDate19 May 2022RegisteredStatusActive

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
Flow Cytometer
Model / Reference
LongCyte C3111
Primary DI / UDI-DI
06975309200205
Basic UDI-DI
697530920026JM
Direct Marketing DI
06975309200205
EMDN Code
W0202040103 Cytoflowmeters - high routine
Device Class
Class A
Market of Registration
Germany

Manufacturer details

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

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 275b4df9-70bc-4697-b590-c2c1e81f9bb3 61 fields · synced 22 Oct 2026