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FlowRACS

by Qingdao Single-Cell Biotech. Co., Ltd. China EUDAMED

Ref FlowRACS HT300 Univ

EMDN W0202040101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69779088403003AR Basic UDI-DIDate29 Apr 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
High-throughput Raman-activated Flow Cytometer
Model / Reference
FlowRACS HT300 Univ
Primary DI / UDI-DI
06977908840004
Basic UDI-DI
69779088403003AR
EMDN Code
W0202040101 Cytoflowmeters - low routine
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000047609
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Qingdao Single-Cell Biotech. 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 a64a82cf-b8be-4ff8-9b0a-bfe75783810a 61 fields · synced 22 Oct 2026