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<eudamedExport entity="devices">
  <row>
    <udiDi>06924030403379</udiDi>
    <basicUdiDi>B-06924030403379</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00222</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403386</udiDi>
    <basicUdiDi>B-06924030403386</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00223</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403393</udiDi>
    <basicUdiDi>B-06924030403393</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403409</udiDi>
    <basicUdiDi>B-06924030403409</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403416</udiDi>
    <basicUdiDi>B-06924030403416</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403423</udiDi>
    <basicUdiDi>B-06924030403423</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00227</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403430</udiDi>
    <basicUdiDi>B-06924030403430</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, 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>MY00228</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403447</udiDi>
    <basicUdiDi>B-06924030403447</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, β2 Glycoprotein 1 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-B2-GLYCOPROTEIN I ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00229</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403454</udiDi>
    <basicUdiDi>B-06924030403454</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, RF 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>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403461</udiDi>
    <basicUdiDi>B-06924030403461</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, RF 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>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00231</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403478</udiDi>
    <basicUdiDi>B-06924030403478</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, RF 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>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00232</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403485</udiDi>
    <basicUdiDi>B-06924030403485</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, RF 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>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00233</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403492</udiDi>
    <basicUdiDi>B-06924030403492</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, CCP</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>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403508</udiDi>
    <basicUdiDi>B-06924030403508</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IAA</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>INSULIN ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00235</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403553</udiDi>
    <basicUdiDi>B-06924030403553</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, human tTG 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>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403560</udiDi>
    <basicUdiDi>B-06924030403560</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, human tTG 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>TISSUE TRANSGLUTAMINASE ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403577</udiDi>
    <basicUdiDi>B-06924030403577</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, DGP 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>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00242</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403584</udiDi>
    <basicUdiDi>B-06924030403584</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, DGP 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>GLIADIN ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403591</udiDi>
    <basicUdiDi>B-06924030403591</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, GAD</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>GAD II ANTIBODIES AND OTHER ICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030403607</udiDi>
    <basicUdiDi>B-06924030403607</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IA2</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>THYROSIN PHOSPHATASE IA2 ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00245</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:23.355Z</lastUpdated>
  </row>
</eudamedExport>