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Flow Cytometer(BioCyte-B4R2V2)

by Biosino Medical Technology (Hefei) Co., Ltd. China EUDAMED

Ref 210007 EMDN W02020499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697739575001FJF Basic UDI-DIDate20 May 2024RegisteredStatusActive

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  • Withdrawn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
Flow Cytometer
Model / Reference
210007
Primary DI / UDI-DI
06977395750077
Basic UDI-DI
697739575001FJF
EMDN Code
W02020499 Flow cytometry instruments - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000041542
Authorised representative
GRZAN GROUP SL ES-AR-000039086

Other devices from Biosino Medical Technology (Hefei) Co., Ltd.

See all devices from Biosino Medical Technology (Hefei) 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 2bac9aa8-cd80-46d3-a94a-49bd2d4a3034 61 fields · synced 22 Oct 2026