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<eudamedExport entity="devices">
  <row>
    <udiDi>06924030404529</udiDi>
    <basicUdiDi>B-06924030404529</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00337</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404574</udiDi>
    <basicUdiDi>B-06924030404574</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00342</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404581</udiDi>
    <basicUdiDi>B-06924030404581</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00343</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404598</udiDi>
    <basicUdiDi>B-06924030404598</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00344</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404604</udiDi>
    <basicUdiDi>B-06924030404604</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00345</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404611</udiDi>
    <basicUdiDi>B-06924030404611</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00346</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404628</udiDi>
    <basicUdiDi>B-06924030404628</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control 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>MY00347</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404635</udiDi>
    <basicUdiDi>B-06924030404635</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, ICA</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>MY00348</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404642</udiDi>
    <basicUdiDi>B-06924030404642</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, PCA</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>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404659</udiDi>
    <basicUdiDi>B-06924030404659</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, Intrinsic Factor</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>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030404666</udiDi>
    <basicUdiDi>B-06924030404666</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, ENA Screen I</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>ENA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405205</udiDi>
    <basicUdiDi>6924030BioCLIACR4E</basicUdiDi>
    <tradeName>BioCLIA System Substrate</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00405</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405274</udiDi>
    <basicUdiDi>6924030BioCLIACR4E</basicUdiDi>
    <tradeName>BioCLIA Sample Diluent I</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00965</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405281</udiDi>
    <basicUdiDi>B-06924030405281</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, CTD 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>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00969</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405298</udiDi>
    <basicUdiDi>B-06924030405298</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, CTD 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>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405304</udiDi>
    <basicUdiDi>B-06924030405304</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, CTD 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>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030409333</udiDi>
    <basicUdiDi>B-06924030409333</basicUdiDi>
    <tradeName>BioCLIA Allergy Reagent Kit, G3</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>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY01190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030409340</udiDi>
    <basicUdiDi>B-06924030409340</basicUdiDi>
    <tradeName>BioCLIA Allergy Reagent Kit, G8</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>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY01191</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030409357</udiDi>
    <basicUdiDi>B-06924030409357</basicUdiDi>
    <tradeName>BioCLIA Allergy Reagent Kit, G12</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>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY01192</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030409364</udiDi>
    <basicUdiDi>B-06924030409364</basicUdiDi>
    <tradeName>BioCLIA Allergy Reagent Kit, T3</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>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY01193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:25:22.139Z</lastUpdated>
  </row>
</eudamedExport>