<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05999862176259</udiDi>
    <basicUdiDi>5999862176BioLyseAXCD</basicUdiDi>
    <tradeName>BioLyse AX Lysing/HGB reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX-2034</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:46.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176235</udiDi>
    <basicUdiDi>5999862176BioDil-5AXRZ</basicUdiDi>
    <tradeName>BioDil-5 AX Diluent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX-1035</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:45.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176211</udiDi>
    <basicUdiDi>5999862176BioDilAXXM</basicUdiDi>
    <tradeName>BioDil AX Diluent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX-1033</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:41.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176174</udiDi>
    <basicUdiDi>5999862176BioCleanCD9C</basicUdiDi>
    <tradeName>BioClean CD Cleaning reagent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-5041</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:40.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176167</udiDi>
    <basicUdiDi>5999862176BGlobinCD3.2NQ</basicUdiDi>
    <tradeName>BioGlobin CD 3.2 Lysing and hemoglobin reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2046</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:40.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176143</udiDi>
    <basicUdiDi>5999862176BLWICCD3.56X</basicUdiDi>
    <tradeName>BioLyse WIC CD 3.5 Lysing and hemoglobin reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2045</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:39.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176129</udiDi>
    <basicUdiDi>5999862176BioLyseCD3J9</basicUdiDi>
    <tradeName>BioLyse CD 3 Lysing and hemoglobin reagent 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2044</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:35.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176105</udiDi>
    <basicUdiDi>5999862176BioLyseCDBB</basicUdiDi>
    <tradeName>BioLyse CD Lysing reagent 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2043</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:35.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176082</udiDi>
    <basicUdiDi>5999862176BioLyseCD3.2FD</basicUdiDi>
    <tradeName>BioLyse CD 3.2 Reagent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2042</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:35.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176068</udiDi>
    <basicUdiDi>5999862176BSheathCD3.5SJ</basicUdiDi>
    <tradeName>BioSheath CD 3.5 Reagent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2041</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:35.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176044</udiDi>
    <basicUdiDi>5999862176BDSheathCD3.2U2</basicUdiDi>
    <tradeName>BioDil-Sheath CD 3.2 Diluent 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-1042</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:29.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176013</udiDi>
    <basicUdiDi>5999862176BioDilCD3.545</basicUdiDi>
    <tradeName>BioDil CD 3.5 Diluent 20L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-1043</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:27.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176006</udiDi>
    <basicUdiDi>5999862176BioHypocleanEG</basicUdiDi>
    <tradeName>BioHypoclean hypochlorite cleaning reagent 1L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioxol Kft</manufacturerName>
    <manufacturerSrn>HU-MF-000025409</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HY-7000</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:41:13.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200580</udiDi>
    <basicUdiDi>59991062iRP26M</basicUdiDi>
    <tradeName>Norma-iRP21</tradeName>
    <deviceName>Norma-iRP21</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91721</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:36:22.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200337</udiDi>
    <basicUdiDi>59991062iClean53E</basicUdiDi>
    <tradeName>Norma-iClean5</tradeName>
    <deviceName>Norma-iClean5</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-51755</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:36:21.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200320</udiDi>
    <basicUdiDi>59991062iLyse5SK</basicUdiDi>
    <tradeName>Norma-iLyse5</tradeName>
    <deviceName>Norma-iLyse5</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-21751</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:36:00.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200306</udiDi>
    <basicUdiDi>59991062iDil5CM</basicUdiDi>
    <tradeName>Norma-iDil5</tradeName>
    <deviceName>Norma-iDil5</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-11755</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:36:00.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200283</udiDi>
    <basicUdiDi>59991062iSol3GQ</basicUdiDi>
    <tradeName>Norma-iSol3</tradeName>
    <deviceName>Norma-iSol3</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-41731</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:59.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200276</udiDi>
    <basicUdiDi>59991062iLyse3SF</basicUdiDi>
    <tradeName>Norma-iLyse3</tradeName>
    <deviceName>Norma-iLyse3</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-21731</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:58.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200252</udiDi>
    <basicUdiDi>59991062iDil3CH</basicUdiDi>
    <tradeName>Norma-iDil3</tradeName>
    <deviceName>Norma-iDil3</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-11735</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:54.558Z</lastUpdated>
  </row>
</eudamedExport>