<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975424224063</udiDi>
    <basicUdiDi>B-06975424224063</basicUdiDi>
    <tradeName>Anti-aPS/PT IgG  CLIA Assay Kit</tradeName>
    <deviceName>Anti-aPS/PT 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>W0102100502</emdnCode>
    <emdnDescription>ANTI-PHOSPHATIDYLSERIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30302EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:04.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224056</udiDi>
    <basicUdiDi>B-06975424224056</basicUdiDi>
    <tradeName>Anti-dsDNA CLIA Assay Kit</tradeName>
    <deviceName>Anti-dsDNA 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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30082EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:03.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224049</udiDi>
    <basicUdiDi>B-06975424224049</basicUdiDi>
    <tradeName>Anti-Scl-70 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Scl-70 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30402EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:02.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224032</udiDi>
    <basicUdiDi>B-06975424224032</basicUdiDi>
    <tradeName>Anti-Sm/nRNP Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Sm/nRNP 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>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30392EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:41:01.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224001</udiDi>
    <basicUdiDi>B-06975424224001</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>CL30352EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:57.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223998</udiDi>
    <basicUdiDi>B-06975424223998</basicUdiDi>
    <tradeName>06975424223998</tradeName>
    <deviceName>Free IgE 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245506</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:57.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224025</udiDi>
    <basicUdiDi>B-06975424224025</basicUdiDi>
    <tradeName>Anti-Ro52 Antibody CLIA Assay Kit</tradeName>
    <deviceName>Anti-Ro52 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL30362EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:56.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424224018</udiDi>
    <basicUdiDi>B-06975424224018</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>CL30382EN</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:55.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223981</udiDi>
    <basicUdiDi>B-06975424223981</basicUdiDi>
    <tradeName>06975424223981</tradeName>
    <deviceName>Total lgE Assay Kit(Fluorescence lmmunoassay)</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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL245206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:39.175Z</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>06975424223967</udiDi>
    <basicUdiDi>B-06975424223967</basicUdiDi>
    <tradeName>06975424223967</tradeName>
    <deviceName>Anti- centromere 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>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234906</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:37.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223950</udiDi>
    <basicUdiDi>B-06975424223950</basicUdiDi>
    <tradeName>06975424223950</tradeName>
    <deviceName>Anti-SSB 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>W0102100113</emdnCode>
    <emdnDescription>SS-B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL244802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:36.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223943</udiDi>
    <basicUdiDi>B-06975424223943</basicUdiDi>
    <tradeName>Anti-SSA Assay Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>Anti-SSA 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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL244702</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:32.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223936</udiDi>
    <basicUdiDi>B-06975424223936</basicUdiDi>
    <tradeName>06975424223936</tradeName>
    <deviceName>Anti-PR3 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>W0102100403</emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234606</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:31.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223929</udiDi>
    <basicUdiDi>B-06975424223929</basicUdiDi>
    <tradeName>06975424223929</tradeName>
    <deviceName>Anti-MPO 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>W0102100402</emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234506</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:30.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223912</udiDi>
    <basicUdiDi>B-06975424223912</basicUdiDi>
    <tradeName>06975424223912</tradeName>
    <deviceName>Anti-Scl-70 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>W0102100110</emdnCode>
    <emdnDescription>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234406</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:29.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223905</udiDi>
    <basicUdiDi>B-06975424223905</basicUdiDi>
    <tradeName>06975424223905</tradeName>
    <deviceName>U1-RNP 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>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234106</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:25.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223899</udiDi>
    <basicUdiDi>B-06975424223899</basicUdiDi>
    <tradeName>06975424223899</tradeName>
    <deviceName>Anti-Sm 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>W0102100111</emdnCode>
    <emdnDescription>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL234006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:25.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223882</udiDi>
    <basicUdiDi>B-06975424223882</basicUdiDi>
    <tradeName>06975424223882</tradeName>
    <deviceName>ANA 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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL233907</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:24.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223875</udiDi>
    <basicUdiDi>B-06975424223875</basicUdiDi>
    <tradeName>06975424223875</tradeName>
    <deviceName>Anti-dsDNA 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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL239206</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:40:23.401Z</lastUpdated>
  </row>
</eudamedExport>