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    <udiDi>06950617420255</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617420255</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4492017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:46:54.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415855</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415855</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:49.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415824</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415824</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:43.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617415800</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617415800</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:41.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950617410843</udiDi>
    <basicUdiDi>69506174IM440017D5</basicUdiDi>
    <tradeName>06950617410843</tradeName>
    <deviceName>HEV IgG Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407017</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T05:45:03.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262351590296</udiDi>
    <basicUdiDi>B-04262351590296</basicUdiDi>
    <tradeName>abia HEV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AB Diagnostic Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK.029.01.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:41:58.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262351590005</udiDi>
    <basicUdiDi>B-04262351590005</basicUdiDi>
    <tradeName>abia HEV IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AB Diagnostic Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK.029.05.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:41:56.281Z</lastUpdated>
  </row>
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