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BioReti-Dye-eco SYS Reticulocyte fluorescent dye 3x12mL

by Bioxol Kft EUDAMED

Active European Union

Ref SY-8022Model BioReti-Dye-eco SYS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5999862176BR-Dye-ecoSYSMK Basic UDI-DIDate5 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
BioReti-Dye-eco SYS, SY-8022
Primary DI / UDI-DI
05999862176655
Basic UDI-DI
5999862176BR-Dye-ecoSYSMK
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000025409

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Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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