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    <basicUdiDi>B-00608337000566</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, Pouched Device</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001-2141</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:25.922Z</lastUpdated>
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    <udiDi>00608337000528</udiDi>
    <basicUdiDi>B-00608337000528</basicUdiDi>
    <tradeName>OraQuick® HCV Rapid Antibody Test Kit Controls</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test Kit Controls</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0278</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:21.904Z</lastUpdated>
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    <udiDi>00628347560980</udiDi>
    <basicUdiDi>62834756AL0206026S</basicUdiDi>
    <tradeName>Artron Hepatitis C Virus (HCV) Antibody Test</tradeName>
    <deviceName>Hepatitis C Virus (HCV) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-06-322P25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:24.571Z</lastUpdated>
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    <udiDi>06952999407510</udiDi>
    <basicUdiDi>B-06952999407510</basicUdiDi>
    <tradeName>06952999407510</tradeName>
    <deviceName>HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-302</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:54.651Z</lastUpdated>
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  <row>
    <udiDi>00628347560997</udiDi>
    <basicUdiDi>62834756AL0206026S</basicUdiDi>
    <tradeName>Acmex Hepatitis C Virus (HCV) Antibody Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-06-322P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.605Z</lastUpdated>
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