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<eudamedExport entity="devices">
  <row>
    <udiDi>06975424220102</udiDi>
    <basicUdiDi>B-06975424220102</basicUdiDi>
    <tradeName>Anti-rRNP0 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-rRNP0 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>W0102100118</emdnCode>
    <emdnDescription>RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:20.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220096</udiDi>
    <basicUdiDi>B-06975424220096</basicUdiDi>
    <tradeName>Anti-PCNA Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-PCNA 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>W0102100599</emdnCode>
    <emdnDescription>ANTI-PHOSPHOLIP SYNDROME - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:19.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220089</udiDi>
    <basicUdiDi>B-06975424220089</basicUdiDi>
    <tradeName>Anti-His Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-His 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>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:19.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220072</udiDi>
    <basicUdiDi>B-06975424220072</basicUdiDi>
    <tradeName>Anti-Nuc Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Nuc 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit.</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:18.300Z</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>06975424220058</udiDi>
    <basicUdiDi>B-06975424220058</basicUdiDi>
    <tradeName>Anti-CENP Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-CENP 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>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:13.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220041</udiDi>
    <basicUdiDi>B-06975424220041</basicUdiDi>
    <tradeName>Anti-PM-Scl Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-PM-Scl 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>W0102100109</emdnCode>
    <emdnDescription>PM-SCL - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:12.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220034</udiDi>
    <basicUdiDi>B-06975424220034</basicUdiDi>
    <tradeName>Anti-SSB CLIA Assay Kit</tradeName>
    <deviceName>Anti-SSB 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>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:36:11.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220027</udiDi>
    <basicUdiDi>B-06975424220027</basicUdiDi>
    <tradeName>Anti-SSA CLIA Assay Kit</tradeName>
    <deviceName>Anti-SSA 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:37.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220010</udiDi>
    <basicUdiDi>B-06975424220010</basicUdiDi>
    <tradeName>Anti-Sm Antibody IgG CLIA Assay Kit</tradeName>
    <deviceName>Anti-Sm Antibody IgG 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>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:36.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424220003</udiDi>
    <basicUdiDi>B-06975424220003</basicUdiDi>
    <tradeName>ANA  Screening Antibody CLIA Assay Kit</tradeName>
    <deviceName>ANA  Screening 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:34:35.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424228092</udiDi>
    <basicUdiDi>697542422SystemWashZ2</basicUdiDi>
    <tradeName>System Wash</tradeName>
    <deviceName>System Wash</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350mL×4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:57:22.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424228085</udiDi>
    <basicUdiDi>697542422SUBSTRATECT</basicUdiDi>
    <tradeName>Chemiluminescent Substrate</tradeName>
    <deviceName>Chemiluminescent Substrate</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100mL×1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:57:21.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223219</udiDi>
    <basicUdiDi>697542422Fluorescence2L</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:57:20.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424226579</udiDi>
    <basicUdiDi>B-06975424226579</basicUdiDi>
    <tradeName>Anti-Scl-70 Antibody CLIA Assay Kit</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL20402EN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T03:48:47.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424222939</udiDi>
    <basicUdiDi>B-06975424222939</basicUdiDi>
    <tradeName>Free T4 CLIA Assay Kit</tradeName>
    <deviceName></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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31062E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:17.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424222922</udiDi>
    <basicUdiDi>B-06975424222922</basicUdiDi>
    <tradeName>Free T3 CLIA Assay Kit</tradeName>
    <deviceName></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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31052E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:15.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424222915</udiDi>
    <basicUdiDi>B-06975424222915</basicUdiDi>
    <tradeName>TSH CLIA Assay Kit</tradeName>
    <deviceName></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>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31012E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:12.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424222908</udiDi>
    <basicUdiDi>B-06975424222908</basicUdiDi>
    <tradeName>T4 CLIA Assay Kit</tradeName>
    <deviceName></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>W01020406</emdnCode>
    <emdnDescription>T- UPTAKE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31042E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:09.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424222892</udiDi>
    <basicUdiDi>B-06975424222892</basicUdiDi>
    <tradeName>T3 CLIA Assay Kit</tradeName>
    <deviceName></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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL31032E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:33:07.412Z</lastUpdated>
  </row>
</eudamedExport>