<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06924030403171</udiDi>
    <basicUdiDi>B-06924030403171</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, nRNP/Sm</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>U1-SNRNP - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403188</udiDi>
    <basicUdiDi>B-06924030403188</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Sm</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>SM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403195</udiDi>
    <basicUdiDi>B-06924030403195</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Jo-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>JO-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403201</udiDi>
    <basicUdiDi>B-06924030403201</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Scl-70</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>SCL-70</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403218</udiDi>
    <basicUdiDi>B-06924030403218</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Ro52</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>MY00206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:24.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403225</udiDi>
    <basicUdiDi>B-06924030403225</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Ribosomal P</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>RIBOSOMAL PHOSPHOPROTEIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403232</udiDi>
    <basicUdiDi>B-06924030403232</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, PCNA</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>MY00208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403249</udiDi>
    <basicUdiDi>B-06924030403249</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403256</udiDi>
    <basicUdiDi>B-06924030403256</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403263</udiDi>
    <basicUdiDi>B-06924030403263</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403270</udiDi>
    <basicUdiDi>B-06924030403270</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403287</udiDi>
    <basicUdiDi>B-06924030403287</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403294</udiDi>
    <basicUdiDi>B-06924030403294</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403300</udiDi>
    <basicUdiDi>B-06924030403300</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403317</udiDi>
    <basicUdiDi>B-06924030403317</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00216</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403324</udiDi>
    <basicUdiDi>B-06924030403324</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403331</udiDi>
    <basicUdiDi>B-06924030403331</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403348</udiDi>
    <basicUdiDi>B-06924030403348</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403355</udiDi>
    <basicUdiDi>B-06924030403355</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403362</udiDi>
    <basicUdiDi>B-06924030403362</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00221</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.742Z</lastUpdated>
  </row>
</eudamedExport>