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<eudamedExport entity="devices">
  <row>
    <udiDi>06925912720317</udiDi>
    <basicUdiDi>692591270249HR</basicUdiDi>
    <tradeName>iFlash-Nuc IgG</tradeName>
    <deviceName>iFlash-Nuc IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86079G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:00.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720300</udiDi>
    <basicUdiDi>692591270257HQ</basicUdiDi>
    <tradeName>iFlash-CenpB IgG</tradeName>
    <deviceName>iFlash-CenpB IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86078G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:59.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912720294</udiDi>
    <basicUdiDi>692591270258HS</basicUdiDi>
    <tradeName>iFlash-Rib-P0 IgG</tradeName>
    <deviceName>iFlash-Rib-P0 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100118</emdnCode>
    <emdnDescription>RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86077G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:59.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912718895</udiDi>
    <basicUdiDi>692591270039HC</basicUdiDi>
    <tradeName>iFlash-ANA</tradeName>
    <deviceName>iFlash-ANA</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89033G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:32:33.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912718796</udiDi>
    <basicUdiDi>692591270038HA</basicUdiDi>
    <tradeName>iFlash-dsDNA IgG</tradeName>
    <deviceName>iFlash-dsDNA IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89015G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:32:18.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023682005</udiDi>
    <basicUdiDi>542502368BDQANA3C</basicUdiDi>
    <tradeName>BlueDiver Quantrix ANA25 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA25Q-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:58.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681824</udiDi>
    <basicUdiDi>542502368BDDGRANULARDB</basicUdiDi>
    <tradeName>BlueDiverDot Granular12 IgG</tradeName>
    <deviceName>BlueDiverDot Granular IgG</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR12DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:56.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681732</udiDi>
    <basicUdiDi>542502368BDDMYOSITISTF</basicUdiDi>
    <tradeName>BlueDiverDot Synthetase10 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN10DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:55.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681725</udiDi>
    <basicUdiDi>542502368BDDSCLERODERMAKH</basicUdiDi>
    <tradeName>BlueDiverDot Scleroderma10 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCL10DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:54.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681589</udiDi>
    <basicUdiDi>542502368BDDPMSCLLT</basicUdiDi>
    <tradeName>BlueDiverDot Polymyositis/Scleroderma8 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS8DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:49.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681428</udiDi>
    <basicUdiDi>542502368BDDCYTOPLASMKG</basicUdiDi>
    <tradeName>BlueDiverDot Cytoplasm6 IgG</tradeName>
    <deviceName>BlueDiverDot Cytoplasm IgG</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY6DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:44.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681398</udiDi>
    <basicUdiDi>542502368BDDCHROMATIN6Y</basicUdiDi>
    <tradeName>BlueDiverDot Chromatin IgG</tradeName>
    <deviceName>BlueDiverDot Chromatin IgG</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHRDIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:43.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023681305</udiDi>
    <basicUdiDi>542502368BDDANAYE</basicUdiDi>
    <tradeName>BlueDiverDot ANA8 IgG</tradeName>
    <deviceName>BlueDiver Dot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA8DIV-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:37.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680902</udiDi>
    <basicUdiDi>542502368BDGRANULARQV</basicUdiDi>
    <tradeName>BlueDot Granular12 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR12D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:36.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680766</udiDi>
    <basicUdiDi>542502368BDSCLERODERMAK9</basicUdiDi>
    <tradeName>BlueDot Scleroderma10 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCL10D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:34.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680742</udiDi>
    <basicUdiDi>542502368BDMYOSITIS74</basicUdiDi>
    <tradeName>BlueDot Myositis7 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYO7D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:32.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680568</udiDi>
    <basicUdiDi>542502368BDCHROMATINFW</basicUdiDi>
    <tradeName>BlueDot Chromatin 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100107</emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHRD-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:30.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680551</udiDi>
    <basicUdiDi>542502368BDPMSCLCN</basicUdiDi>
    <tradeName>BlueDot Polymyositis/Scleroderma8 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>IVDR 2017/746</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMS8D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:28.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680407</udiDi>
    <basicUdiDi>542502368BDCYTOPLASMUE</basicUdiDi>
    <tradeName>BlueDot Cytoplasm6 IgG</tradeName>
    <deviceName>BlueDot Cytoplasm</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY6D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:22.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425023680308</udiDi>
    <basicUdiDi>542502368BDANAZF</basicUdiDi>
    <tradeName>BlueDot ANA8 IgG</tradeName>
    <deviceName>BlueDot ANA Screening</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANA8D-24</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:03:18.557Z</lastUpdated>
  </row>
</eudamedExport>