<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06924030402129</udiDi>
    <basicUdiDi>B-06924030402129</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit dsDNA</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>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00097</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:45.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416409</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Cardiolipin IgA</tradeName>
    <deviceName>BioCLIA Autoimmune Reagent Kit,BioCLIA Autoimmune Calibrator Set, BioCLIA Autoimmune Control Set</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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTO-IMMUNE DISEASE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02197C</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:56.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030405199</udiDi>
    <basicUdiDi>6924030BioCLIACR4E</basicUdiDi>
    <tradeName>BioCLIA System Wash Buffer</tradeName>
    <deviceName>BioCLIA Sample Diluent I,BioCLIA System Wash Buffer,BioCLIA System Substrate</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>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY00404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:29:55.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416966</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02291</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:55.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416959</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02292C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:52.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416973</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02293</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:39.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416980</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MY02295</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:38.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416997</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02294</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:37.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030417000</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, IgG4</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02296</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:37.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030417017</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, C1q</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02287</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:38:17.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030417024</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, C1q</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02289</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:38:15.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030417031</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, MDA5 (Chemiluminescent Microparticle Immunoassay)</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02288</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:37:58.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030417048</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, C1q</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:37:48.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416874</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Ku</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02273</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:56:10.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416881</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Ku</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02276C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:56:05.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416898</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Ku</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02281</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:56.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416904</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Control Set, Ku</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02282</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:54.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416836</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Mi-2</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02274</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:52.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416843</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Reagent Kit, Mi-2</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02275C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:53:23.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06924030416850</udiDi>
    <basicUdiDi>6924030BioCLIAAI3N</basicUdiDi>
    <tradeName>BioCLIA Autoimmune Calibrator Set, Mi-2</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MY02277</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:52:57.464Z</lastUpdated>
  </row>
</eudamedExport>