<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05999106200641</udiDi>
    <basicUdiDi>59991062iLyse5SK</basicUdiDi>
    <tradeName>Norma-iLyse5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</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>IC-21751</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:48:40.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200658</udiDi>
    <basicUdiDi>59991062iClean53E</basicUdiDi>
    <tradeName>Norma-iClean5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</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>IC-51755</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:48:40.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200849</udiDi>
    <basicUdiDi>59991062iHCleanV4</basicUdiDi>
    <tradeName>H3/5-Hypoclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</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>HE3413</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:48:40.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200856</udiDi>
    <basicUdiDi>59991062iOptiCleanC4</basicUdiDi>
    <tradeName>H5-Opticlean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</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>HE3422</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:48:40.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176020</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>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-1043</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176051</udiDi>
    <basicUdiDi>5999862176BDSheathCD3.2U2</basicUdiDi>
    <tradeName>BioDil-Sheath CD 3.2 Diluent 20L</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>CD-1042</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176075</udiDi>
    <basicUdiDi>5999862176BSheathCD3.5SJ</basicUdiDi>
    <tradeName>BioSheath CD 3.5 Reagent 20L</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>CD-2041</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176099</udiDi>
    <basicUdiDi>5999862176BioLyseCD3.2FD</basicUdiDi>
    <tradeName>BioLyse CD 3.2 Reagent 5L</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>CD-2042</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176112</udiDi>
    <basicUdiDi>5999862176BioLyseCDBB</basicUdiDi>
    <tradeName>BioLyse CD Lysing 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>CD-2043</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176136</udiDi>
    <basicUdiDi>5999862176BioLyseCD3J9</basicUdiDi>
    <tradeName>BioLyse CD 3 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>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2044</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176150</udiDi>
    <basicUdiDi>5999862176BLWICCD3.56X</basicUdiDi>
    <tradeName>BioLyse WIC CD 3.5 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>UNKNOWN</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD-2045</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:03.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176181</udiDi>
    <basicUdiDi>5999862176BioCleanCD9C</basicUdiDi>
    <tradeName>BioClean CD Cleaning reagent 20L</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>CD-5041</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176204</udiDi>
    <basicUdiDi>5999862176BioRetiCD7Q</basicUdiDi>
    <tradeName>BioReti Reticulocyte reagent 50mL</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>CD-8041</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176228</udiDi>
    <basicUdiDi>5999862176BioDilAXXM</basicUdiDi>
    <tradeName>BioDil AX Diluent 20L</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>AX-1033</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176242</udiDi>
    <basicUdiDi>5999862176BioDil-5AXRZ</basicUdiDi>
    <tradeName>BioDil-5 AX Diluent 20L</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>AX-1035</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176266</udiDi>
    <basicUdiDi>5999862176BioLyseAXCD</basicUdiDi>
    <tradeName>BioLyse AX Lysing/HGB reagent 0.4L</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>AX-2034</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176280</udiDi>
    <basicUdiDi>5999862176BioL-BASO-2AXK8</basicUdiDi>
    <tradeName>BioLyse-BASO-2 AX Basophil reagent 0.5L</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>AX-2035</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176303</udiDi>
    <basicUdiDi>5999862176BioL-BASOAX7P</basicUdiDi>
    <tradeName>BioLyse-BASO AX Basophil 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>AX-2037</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176327</udiDi>
    <basicUdiDi>5999862176BioCleanAXAE</basicUdiDi>
    <tradeName>BioClean AX Cleaning reagent 5L</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>AX-5035</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999862176341</udiDi>
    <basicUdiDi>5999862176BioFix-EOAXB8</basicUdiDi>
    <tradeName>BioFix-EO AX Eosinophil/LMNE reagent 0.5L</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>AX-2036</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:02.589Z</lastUpdated>
  </row>
</eudamedExport>