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BasoFlowEx Kit

by EXBIO Praha, a.s. EUDAMED

Active European Union

Ref ED7043

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number859420806ED704364 Basic UDI-DIDate22 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-IVDR/QS-002 Issued

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    30 Jun 2025
    Expires
    11 Jun 2029

Specification

EUDAMED

Device Name
BasoFlowEx Kit
Model / Reference
ED7043
Primary DI / UDI-DI
08594208060130
Basic UDI-DI
859420806ED704364
Direct Marketing DI
08594208060130
EMDN Code
W0103080699 Reagents for flow cytometry - other
Device Class
Class B
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000033468

Other devices from EXBIO Praha, a.s.

See all devices from EXBIO Praha, a.s. →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No