<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05999106200009</udiDi>
    <basicUdiDi>59991062Icon3A2</basicUdiDi>
    <tradeName>Norma Icon-3 automated 3-part differential hematology analyzer</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></emdnCode>
    <emdnDescription>AUTOMATED 3 PART HEMATOLOGY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NI30H</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200016</udiDi>
    <basicUdiDi>59991062Icon5A6</basicUdiDi>
    <tradeName>Norma Icon-5 automated 5-part differential hematology analyzer with closed sampling method</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></emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NI50H</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200023</udiDi>
    <basicUdiDi>59991062Icon5OPU7</basicUdiDi>
    <tradeName>Norma Icon-5 OP automated 5-part differential hematology analyzer with open sampling method</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></emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NO50H</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200047</udiDi>
    <basicUdiDi>59991062AutoloaderGH</basicUdiDi>
    <tradeName>Norma Autoloader accessory unit for automated sample vial loading</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></emdnCode>
    <emdnDescription>AUTOMATED SAMPLE TRANSPORT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NICA-AL50</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:02.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200054</udiDi>
    <basicUdiDi>59991062iRP36P</basicUdiDi>
    <tradeName>Norma-iRP31</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91711</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200061</udiDi>
    <basicUdiDi>59991062iRP36P</basicUdiDi>
    <tradeName>Norma-iRP35</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91715</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200078</udiDi>
    <basicUdiDi>59991062iRP56T</basicUdiDi>
    <tradeName>Norma-iRP51</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91751</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200085</udiDi>
    <basicUdiDi>59991062iRP56T</basicUdiDi>
    <tradeName>Norma-iRP54</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91754</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200092</udiDi>
    <basicUdiDi>59991062iRP5OPC2</basicUdiDi>
    <tradeName>Norma-iRP51 OP</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91771</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200108</udiDi>
    <basicUdiDi>59991062iRP5OPC2</basicUdiDi>
    <tradeName>Norma-iRP52 OP</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-91772</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.877Z</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></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></emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200139</udiDi>
    <basicUdiDi>59991062NormaCont36B</basicUdiDi>
    <tradeName>NormaCont3+ KIT KL control blood set for 3-part differential Norma hematology analyzers - 6 low vials</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></emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032KL</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200146</udiDi>
    <basicUdiDi>59991062NormaCont36B</basicUdiDi>
    <tradeName>NormaCont3+ KIT KN control blood set for 3-part differential Norma hematology analyzers - 6 normal vials</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></emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032KN</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200153</udiDi>
    <basicUdiDi>59991062NormaCont36B</basicUdiDi>
    <tradeName>NormaCont3+ KIT KH control blood set for 3-part differential Norma hematology analyzers - 6 high vials</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></emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-032KH</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.770Z</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></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></emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053K1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200177</udiDi>
    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>NormaCont5+ KIT KL control blood set for 5-part differential Norma hematology analyzers - 6 low vials</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></emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053KL</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200184</udiDi>
    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>NormaCont5+ KIT KN control blood set for 5-part differential Norma hematology analyzers - 6 normal vials</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></emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053KN</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200191</udiDi>
    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>NormaCont5+ KIT KH control blood set for 5-part differential Norma hematology analyzers - 6 high vials</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></emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-053KH</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200207</udiDi>
    <basicUdiDi>59991062NormaCalZ8</basicUdiDi>
    <tradeName>NormaCal3 calibrator for Norma hematology analyzers</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></emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-CAL32</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999106200214</udiDi>
    <basicUdiDi>59991062iHCleanV4</basicUdiDi>
    <tradeName>Norma-iHClean</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></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IC-81731</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:01.618Z</lastUpdated>
  </row>
</eudamedExport>