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<eudamedExport entity="devices">
  <row>
    <udiDi>05425023681794</udiDi>
    <basicUdiDi>542502368BDDANAYE</basicUdiDi>
    <tradeName>BlueDiverDot PRL12 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>W0102100101</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRL12DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:09.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681800</udiDi>
    <basicUdiDi>542502368BDDSCLERODERMAKH</basicUdiDi>
    <tradeName>BlueDiverDot Scleroderma12 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCL12DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:09.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681817</udiDi>
    <basicUdiDi>542502368BDDCHROMATIN6Y</basicUdiDi>
    <tradeName>BlueDiverDot Chromatin4 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>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHR4DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:09.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023682036</udiDi>
    <basicUdiDi>542502368BDQANA3C</basicUdiDi>
    <tradeName>BlueDiver Quantrix ANA19 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA19Q-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:24:08.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687000</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>ANA + DFS70 IgG 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ANADFD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687017</udiDi>
    <basicUdiDi>542502368BDGRANULARQV</basicUdiDi>
    <tradeName>ANA Granular 12Ag IgG 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ANAGR12D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687024</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>ANA Mi-2 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ANAMID</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687086</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>Connectivitis 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD CP10D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687093</udiDi>
    <basicUdiDi>542502368BDCYTOPLASMUE</basicUdiDi>
    <tradeName>Cytoplasmic Profile6 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>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD CYTO6D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687109</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>ENA 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ENA10D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687116</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>ENA 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>W0102100101</emdnCode>
    <emdnDescription>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ENAD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687123</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>ENA Screen 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD ENASD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687130</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>FULL ANA 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD FULLANAD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687208</udiDi>
    <basicUdiDi>542502368BDMYOSITIS74</basicUdiDi>
    <tradeName>Myositis Profile 12 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>W0102100199</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MYOS12AD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687215</udiDi>
    <basicUdiDi>542502368BDMYOSITIS74</basicUdiDi>
    <tradeName>Myositis Profile 12 Ag OJ 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>W0102100199</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD MYOSO12AD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687222</udiDi>
    <basicUdiDi>542502368BDCHROMATINFW</basicUdiDi>
    <tradeName>NDH Chromatin 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>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD NDHD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687239</udiDi>
    <basicUdiDi>542502368BDCHROMATINFW</basicUdiDi>
    <tradeName>NDH Chromatin + DFS70 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>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD NDHDFSD</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687246</udiDi>
    <basicUdiDi>542502368BDSCLERODERMAK9</basicUdiDi>
    <tradeName>Scleroderma 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD SCLERO10D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687253</udiDi>
    <basicUdiDi>542502368BDSCLERODERMAK9</basicUdiDi>
    <tradeName>Scleroderma Profile 12 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD SCLERO12D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023687260</udiDi>
    <basicUdiDi>542502368BDPMSCLCN</basicUdiDi>
    <tradeName>Sclero-Poly- Synthetase Profile 8 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>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD SPS8D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:23:50.089Z</lastUpdated>
  </row>
</eudamedExport>