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<eudamedExport entity="devices">
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    <udiDi>05992790341010</udiDi>
    <basicUdiDi>5992790D27HK</basicUdiDi>
    <tradeName>DiaSheath U II</tradeName>
    <deviceName>DiaSheath U II</deviceName>
    <manufacturerName>Diagon Diagnosztikai Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000023582</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>h34101</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:28:52.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486035985</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName>AUTION EYE Sheath Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:41.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73811HV</udiDi>
    <basicUdiDi>B-73811HV</basicUdiDi>
    <tradeName>AUTION Sheath Solution</tradeName>
    <deviceName>AUTION Sheath Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73811</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:22.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73810HT</udiDi>
    <basicUdiDi>B-73810HT</basicUdiDi>
    <tradeName>AUTION Staining Solution (BAC)</tradeName>
    <deviceName>AUTION Staining Solution (BAC)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73810</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:21.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73809JA</udiDi>
    <basicUdiDi>B-73809JA</basicUdiDi>
    <tradeName>AUTION Staining Solution (SED)</tradeName>
    <deviceName>AUTION Staining Solution (SED)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73809</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:20.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73808J8</udiDi>
    <basicUdiDi>B-73808J8</basicUdiDi>
    <tradeName>AUTION Diluent (BAC)</tradeName>
    <deviceName>AUTION Diluent (BAC)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73808</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73807J6</udiDi>
    <basicUdiDi>B-73807J6</basicUdiDi>
    <tradeName>AUTION Diluent (SED)</tradeName>
    <deviceName>AUTION Diluent (SED)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73807</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:15.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105582MU</udiDi>
    <basicUdiDi>B-105582MU</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName>AUTION EYE Sheath Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105582</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:30.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142235011</udiDi>
    <basicUdiDi>859514221377084</basicUdiDi>
    <tradeName>FEHLING II ROZTOK</tradeName>
    <deviceName>FEHLING II ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13770-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:50.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142234915</udiDi>
    <basicUdiDi>85951422137607Z</basicUdiDi>
    <tradeName>FEHLING I ROZTOK</tradeName>
    <deviceName>FEHLING I ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13760-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:49.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486035992</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107665</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:21.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040125</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108521</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040132</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108522</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040149</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108523</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040156</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108524</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040163</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108525</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486040170</udiDi>
    <basicUdiDi>4987486BC0107664HF</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108526</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:02.555Z</lastUpdated>
  </row>
</eudamedExport>