<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-CK-2485-100M8R</udiDi>
    <basicUdiDi>B-CK-2485-100M8R</basicUdiDi>
    <tradeName>D-CK-2485-100M8R</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:26.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-100G8D</udiDi>
    <basicUdiDi>B-CK-2485-100G8D</basicUdiDi>
    <tradeName>D-CK-2485-100G8D</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:24.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-100A7Z</udiDi>
    <basicUdiDi>B-CK-2485-100A7Z</basicUdiDi>
    <tradeName>D-CK-2485-100A7Z</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-100A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:22.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-050M9B</udiDi>
    <basicUdiDi>B-CK-2485-050M9B</basicUdiDi>
    <tradeName>D-CK-2485-050M9B</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:22.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-050G8X</udiDi>
    <basicUdiDi>B-CK-2485-050G8X</basicUdiDi>
    <tradeName>D-CK-2485-050G8X</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:20.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2485-050A8K</udiDi>
    <basicUdiDi>B-CK-2485-050A8K</basicUdiDi>
    <tradeName>D-CK-2485-050A8K</tradeName>
    <deviceName>Human anti-CA6 antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2485-050A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-100M8C</udiDi>
    <basicUdiDi>B-CK-2484-100M8C</basicUdiDi>
    <tradeName>D-CK-2484-100M8C</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-100M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-100G7Y</udiDi>
    <basicUdiDi>B-CK-2484-100G7Y</basicUdiDi>
    <tradeName>D-CK-2484-100G7Y</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-100G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:18.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-100A7L</udiDi>
    <basicUdiDi>B-CK-2484-100A7L</basicUdiDi>
    <tradeName>D-CK-2484-100A7L</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-100A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:13.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-050M8W</udiDi>
    <basicUdiDi>B-CK-2484-050M8W</basicUdiDi>
    <tradeName>D-CK-2484-050M8W</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgM)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-050M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:11.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-050G8J</udiDi>
    <basicUdiDi>B-CK-2484-050G8J</basicUdiDi>
    <tradeName>D-CK-2484-050G8J</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgG)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-050G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:10.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CK-2484-050A86</udiDi>
    <basicUdiDi>B-CK-2484-050A86</basicUdiDi>
    <tradeName>D-CK-2484-050A86</tradeName>
    <deviceName>Human anti-parotid secretory protein antibody CLIA Kit (IgA)</deviceName>
    <manufacturerName>Guangzhou Kangrun Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032267</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100199</emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-2484-050A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T02:06:07.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-C89045GC3</udiDi>
    <basicUdiDi>B-C89045GC3</basicUdiDi>
    <tradeName>iFlash-RNP70 IgG</tradeName>
    <deviceName>iFlash-RNP70 IgG</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100114</emdnCode>
    <emdnDescription>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C89045G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:54:26.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313273256</udiDi>
    <basicUdiDi>B-86060313273256</basicUdiDi>
    <tradeName>Nucleo-h</tradeName>
    <deviceName>Nucleo-h</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>W0102100117</emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N719ANUC</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:33.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147196806</udiDi>
    <basicUdiDi>B-86060147196806</basicUdiDi>
    <tradeName>Anti-SS-A</tradeName>
    <deviceName>Anti-SS-A</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>W0102100112</emdnCode>
    <emdnDescription>SS-A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N704A24SSA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:33.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147196424</udiDi>
    <basicUdiDi>B-86060147196424</basicUdiDi>
    <tradeName>ANA screen</tradeName>
    <deviceName>ANA screen</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>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N707A24ANA</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:27.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147195748</udiDi>
    <basicUdiDi>B-86060147195748</basicUdiDi>
    <tradeName>Anti-dsDNA IgM</tradeName>
    <deviceName>Anti-dsDNA IgM</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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N710A24DNM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:26.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147195670</udiDi>
    <basicUdiDi>B-86060147195670</basicUdiDi>
    <tradeName>Anti-dsDNA IgG</tradeName>
    <deviceName>Anti-dsDNA IgG</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>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N709A24DNG</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:25.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060147194062</udiDi>
    <basicUdiDi>B-86060147194062</basicUdiDi>
    <tradeName>Centromere</tradeName>
    <deviceName>Centromere</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>W0102100115</emdnCode>
    <emdnDescription>ANTI-CENTROMERE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N715A24CNM</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:00.181Z</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>
</eudamedExport>