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<eudamedExport entity="devices">
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    <udiDi>06942359513418</udiDi>
    <basicUdiDi>697015090000316HE</basicUdiDi>
    <tradeName>AMA-M2 IgG CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100702</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ2408</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:51:13.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680599</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>BlueDot Liver7 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI7D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:19.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680650</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>BlueDot Liver10 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI10D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:19.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680667</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>BlueDot Mitochondria2 IgG + IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI2D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:19.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681503</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>BlueDiverDot Liver7 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI7DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:18.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681596</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>BlueDiverDot Liver10 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LI10DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:18.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681619</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>BlueDiverDot Mitochondria2 IgG + IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI2DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:09.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687154</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>Liver Profile 7 Ag Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVER7D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687161</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>Liver Profile 10 Ag Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVER10D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687178</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>Liver Profile Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVERD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687185</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>Mitochondria Profile 2 Ag IgG + IgM Dot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MI2D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687451</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>Liver Profile 7 Ag Dot for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVER7DBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687468</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>Liver Profile 10 Ag Dot for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVER10DBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687482</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>Mitochondria Profile 2 Ag IgG+IgM Dot for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MI2DBD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687611</udiDi>
    <basicUdiDi>542502368BDQLIVERQV</basicUdiDi>
    <tradeName>Liver Profile 10 Ag IgG Microarrays for BDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD LIVER10DBDM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023688083</udiDi>
    <basicUdiDi>542502368BDLIVERBF</basicUdiDi>
    <tradeName>DIASpot Liver7 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTLI7</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:49.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023688236</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>DIASpot Neptune Liver5 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTLISN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:48.957Z</lastUpdated>
  </row>
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    <udiDi>05425023688243</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>DIASpot Neptune Liver7 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTLI7N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:48.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023688250</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>DIASpot Neptune Liver10 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTLI10N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:48.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023688267</udiDi>
    <basicUdiDi>542502368BDDLIVERKL</basicUdiDi>
    <tradeName>DIASpot Neptune Mitochondria2 IgG + IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100703</emdnCode>
    <emdnDescription>ANTI-MITOCHONDRIAL ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAPDTMI2N</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:48.890Z</lastUpdated>
  </row>
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