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<eudamedExport entity="devices">
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
  <row>
    <udiDi>05999106200238</udiDi>
    <basicUdiDi>59991062iOptiCleanC4</basicUdiDi>
    <tradeName>Norma-iOptiClean</tradeName>
    <deviceName>Norma-iOptiClean</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-81750</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:53.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200214</udiDi>
    <basicUdiDi>59991062iHCleanV4</basicUdiDi>
    <tradeName>Norma-iHClean</tradeName>
    <deviceName>Norma-iHClean</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-81731</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:52.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200207</udiDi>
    <basicUdiDi>59991062NormaCalZ8</basicUdiDi>
    <tradeName>NormaCal3 calibrator for Norma hematology analyzers</tradeName>
    <deviceName>NormaCal3 calibrator for Norma hematology analyzers</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-CAL32</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:52.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200160</udiDi>
    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials</tradeName>
    <deviceName>NormaCont5+ KIT K1 control blood set for 5-part differential Norma hematology analyzers</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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:48.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200092</udiDi>
    <basicUdiDi>59991062iRP5OPC2</basicUdiDi>
    <tradeName>Norma-iRP51 OP</tradeName>
    <deviceName>Norma-iRP51 OP</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-91771</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:47.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200122</udiDi>
    <basicUdiDi>59991062NormaCont36B</basicUdiDi>
    <tradeName>NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers - 2 low, 2 normal and 2 high vials</tradeName>
    <deviceName>NormaCont3+ KIT K1 control blood set for 3-part differential Norma hematology analyzers</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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:46.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200078</udiDi>
    <basicUdiDi>59991062iRP56T</basicUdiDi>
    <tradeName>Norma-iRP51</tradeName>
    <deviceName>Norma-iRP51</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-91751</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:45.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200054</udiDi>
    <basicUdiDi>59991062iRP36P</basicUdiDi>
    <tradeName>Norma-iRP31</tradeName>
    <deviceName>Norma-iRP31</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-91711</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:40.943Z</lastUpdated>
  </row>
</eudamedExport>