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<eudamedExport entity="devices">
  <row>
    <udiDi>04712803531303</udiDi>
    <basicUdiDi>B-04712803531303</basicUdiDi>
    <tradeName>NANBASE C-96 V4.0</tradeName>
    <deviceName>NANBASE C-96 V4.0</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4NAE12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:31.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04712803531297</udiDi>
    <basicUdiDi>B-04712803531297</basicUdiDi>
    <tradeName>NANBASE C-96 V4.0</tradeName>
    <deviceName>NANBASE C-96 V4.0</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4NAE3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:48:28.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M52107106LG</udiDi>
    <basicUdiDi>B-++M52107106LG</basicUdiDi>
    <tradeName>EIAgen HCV Ab (v.4) Kit</tradeName>
    <deviceName>EIAgen HCV Ab (v.4)</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071067 / 071064 / 071068</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z1350058</udiDi>
    <basicUdiDi>B-Z1350058</basicUdiDi>
    <tradeName>D-Z1350058</tradeName>
    <deviceName>HCV Ab Sensitive</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z13500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:52:04.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z133705K</udiDi>
    <basicUdiDi>B-Z133705K</basicUdiDi>
    <tradeName>D-Z133705K</tradeName>
    <deviceName>HCV Ab Sensitive</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z13370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:59.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08887581000498</udiDi>
    <basicUdiDi>B-08887581000498</basicUdiDi>
    <tradeName>MP Diagnostics HCV ELISA 4.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MP Biomedicals Asia Pacific Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000024819</manufacturerSrn>
    <authorisedRepresentativeName>MP Biomedicals Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000020992</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23130-096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:22:17.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-06936983106009W4</udiDi>
    <basicUdiDi>B-06936983106009W4</basicUdiDi>
    <tradeName>HCV Rapid Test</tradeName>
    <deviceName>HCV Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:24:38.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200704</udiDi>
    <basicUdiDi>B-00686597200704</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE fr 50 and INSTI HCV Ab Test CE fr 300</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-005 and 90-1062-006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:05.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200674</udiDi>
    <basicUdiDi>B-00686597200674</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE en 25, INSTI HCV Ab Test CE en 50 and INSTI HCV Ab Test CE 300</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-001, 90-1062-002, and 90-1062-003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:04.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074563610</udiDi>
    <basicUdiDi>8905459MHCVRT9A</basicUdiDi>
    <tradeName>MERISCREEN HCV</tradeName>
    <deviceName>MERISCREEN HCV</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHCV-01                   RPDHCV-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:50.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452454</udiDi>
    <basicUdiDi>B-06970301452454</basicUdiDi>
    <tradeName>06970301452454</tradeName>
    <deviceName>AiD anti-HCV ELISA Plus</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WC-31S480</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:25:58.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452447</udiDi>
    <basicUdiDi>B-06970301452447</basicUdiDi>
    <tradeName>06970301452447</tradeName>
    <deviceName>AiD anti-HCV ELISA Plus</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WC-31S96</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:25:52.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983106009</udiDi>
    <basicUdiDi>B-06936983106009</basicUdiDi>
    <tradeName>HCV Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:55:46.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804313</udiDi>
    <basicUdiDi>B-06936155804313</basicUdiDi>
    <tradeName>06936155804313</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01153-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:09.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804306</udiDi>
    <basicUdiDi>B-06936155804306</basicUdiDi>
    <tradeName>06936155804306</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01153-TC10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:07.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804290</udiDi>
    <basicUdiDi>B-06936155804290</basicUdiDi>
    <tradeName>06936155804290</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP01152-TC40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:05.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155804283</udiDi>
    <basicUdiDi>B-06936155804283</basicUdiDi>
    <tradeName>06936155804283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP01152-TC25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:04.234Z</lastUpdated>
  </row>
</eudamedExport>