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BioDil-5 AX Diluent 20L

by Bioxol Kft Hungary EUDAMED

Ref AX-1035Model BioDil-5 AX EMDN W0103010105

Overview

For reliable and accurate biochemistry laboratory testing, the BioDil-5 AX Diluent 20L is a high-quality diluent designed for human and animal tissue analysis. It combines precision and convenience with safety and regulatory compliance. Made by Bioxol Kft, this diluted solution is suitable for various medical applications.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5999862176BioDil-5AXRZ Basic UDI-DIDate31 Jan 2023RegisteredStatusActive

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  • Withdrawn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

Model / Reference
BioDil-5 AX, AX-1035
Primary DI / UDI-DI
05999862176242
Basic UDI-DI
5999862176BioDil-5AXRZ
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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See all devices from Bioxol Kft →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 80015969-fc5d-4a41-88a0-7c41cd6fd21f 61 fields · synced 22 Oct 2026