<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06924030402730</udiDi>
    <basicUdiDi>B-06924030402730</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, PM-Scl</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PM-SCL - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00158</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402747</udiDi>
    <basicUdiDi>B-06924030402747</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Histone</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HISTONES (H1, H2A, H3, H4,…HN)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00159</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402754</udiDi>
    <basicUdiDi>B-06924030402754</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, CENP-B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402761</udiDi>
    <basicUdiDi>B-06924030402761</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Nucleosome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEOSOME ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402778</udiDi>
    <basicUdiDi>B-06924030402778</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, MPO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MPO ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00162</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402785</udiDi>
    <basicUdiDi>B-06924030402785</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, PR3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PR3 ANCA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402792</udiDi>
    <basicUdiDi>B-06924030402792</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, GBM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VASCULITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00164</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402808</udiDi>
    <basicUdiDi>B-06924030402808</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, gp210</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402815</udiDi>
    <basicUdiDi>B-06924030402815</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, sp100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SP 100 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402822</udiDi>
    <basicUdiDi>B-06924030402822</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, LKM-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LKM1 AND RELATED PROTEINS ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00167</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402839</udiDi>
    <basicUdiDi>B-06924030402839</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, LC-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00168</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402846</udiDi>
    <basicUdiDi>B-06924030402846</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, AMA-M2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00169</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402853</udiDi>
    <basicUdiDi>B-06924030402853</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, SLA/LP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOIMMUNE HEPATITIS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402860</udiDi>
    <basicUdiDi>B-06924030402860</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00171</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402877</udiDi>
    <basicUdiDi>B-06924030402877</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00172</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402884</udiDi>
    <basicUdiDi>B-06924030402884</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402891</udiDi>
    <basicUdiDi>B-06924030402891</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin Screen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-CARDIOLIPIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00174</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402907</udiDi>
    <basicUdiDi>B-06924030402907</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00175</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402914</udiDi>
    <basicUdiDi>B-06924030402914</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00176</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030402921</udiDi>
    <basicUdiDi>B-06924030402921</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOB Biotech Group Corp., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023974</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ANTI-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00177</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.523Z</lastUpdated>
  </row>
</eudamedExport>