<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942359545068</udiDi>
    <basicUdiDi>697015090000309HH</basicUdiDi>
    <tradeName>Anti-Jo-1 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>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1903</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:49:57.731Z</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>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>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>04250289500555</udiDi>
    <basicUdiDi>B-04250289500555</basicUdiDi>
    <tradeName>AESKULISA® Jo-1</tradeName>
    <deviceName>AESKULISA® Jo-1</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3113</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T15:37:56.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4409260KB</udiDi>
    <basicUdiDi>B-IM4409260KB</basicUdiDi>
    <tradeName>D-IM4409260KB</tradeName>
    <deviceName>Anti-Jo-1 Antibody Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4409260</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:30:31.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147193904</udiDi>
    <basicUdiDi>B-86060147193904</basicUdiDi>
    <tradeName>Jo-1</tradeName>
    <deviceName>Jo-1</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N714A24JO1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:13:59.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359545082</udiDi>
    <basicUdiDi>697015090000309HH</basicUdiDi>
    <tradeName>Anti-Jo-1 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>UNKNOWN</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMQ1905</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:19.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226975</udiDi>
    <basicUdiDi>B-06975424226975</basicUdiDi>
    <tradeName>Anti-Jo-1 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Jo-1 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30312EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:48:00.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226500</udiDi>
    <basicUdiDi>B-06975424226500</basicUdiDi>
    <tradeName>Anti-Jo-1 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Jo-1 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20312EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:46:26.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225657</udiDi>
    <basicUdiDi>B-06975424225657</basicUdiDi>
    <tradeName>Anti-Jo-1 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Jo-1 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL235001C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:43:24.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223974</udiDi>
    <basicUdiDi>B-06975424223974</basicUdiDi>
    <tradeName>06975424223974</tradeName>
    <deviceName>Anti-Jo-1  Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL235006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:37.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424221925</udiDi>
    <basicUdiDi>B-06975424221925</basicUdiDi>
    <tradeName>Anti-Jo-1 Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-Jo-1 Assay Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:37:10.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220065</udiDi>
    <basicUdiDi>B-06975424220065</basicUdiDi>
    <tradeName>Anti-Jo-1 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Jo-1 Antibody CLIA Assay Kit</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:14.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070769437</udiDi>
    <basicUdiDi>B-06975070769437</basicUdiDi>
    <tradeName>Sharay Anti-Jo-1 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Jo-1 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000731</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:50:54.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070766313</udiDi>
    <basicUdiDi>B-06975070766313</basicUdiDi>
    <tradeName>Sharay Anti-Myositis Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Myositis Antibody Profile IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:26.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070761646</udiDi>
    <basicUdiDi>B-06975070761646</basicUdiDi>
    <tradeName>Sharay Anti-Myositis Antibody Profile IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Myositis Antibody Profile IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>18177001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:11.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975070760991</udiDi>
    <basicUdiDi>B-06975070760991</basicUdiDi>
    <tradeName>Sharay Anti-Jo-1 IgG (CLIA)</tradeName>
    <deviceName>Sharay Anti-Jo-1 IgG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100108</emdnCode>
    <emdnDescription>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18115001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:33:12.677Z</lastUpdated>
  </row>
</eudamedExport>