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CD34 QuantiFlowEx Kit

by EXBIO Praha, a.s. EUDAMED

Active European Union

Ref ED7080

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number859420806ED70806A Basic UDI-DIDate25 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  • Withdrawn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)
  • 2024-IVDR/QS-004 Supplemented

    Quality management system EU IVDR

    Notified body
    3EC International a.s. 2265
    Issued
    4 Dec 2024
    Expires
    11 Jun 2029
    Reason
    Add device or group

Specification

EUDAMED

Device Name
CD34 QuantiFlowEx Kit
Model / Reference
ED7080
Primary DI / UDI-DI
08594208060048
Basic UDI-DI
859420806ED70806A
Direct Marketing DI
08594208060048
EMDN Code
W01030803 Stem cell enumeration reagents
Device Class
Class C
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

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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