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<eudamedExport entity="devices">
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    <udiDi>20608337000560</udiDi>
    <basicUdiDi>B-20608337000560</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 25 Count</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>1001-0270</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:06:15.808Z</lastUpdated>
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    <udiDi>D-1001-0371C2</udiDi>
    <basicUdiDi>B-1001-0371C2</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test</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>Artık piyasada değil</deviceStatus>
    <reference>1001-0371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:49:07.166Z</lastUpdated>
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    <udiDi>D-1001-0370BY</udiDi>
    <basicUdiDi>B-1001-0370BY</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 25 Count, Korea</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>Artık piyasada değil</deviceStatus>
    <reference>1001-0370</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:49:06.371Z</lastUpdated>
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    <udiDi>D-IHCV-C31JH</udiDi>
    <basicUdiDi>B-IHCV-C31JH</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>HCV Rapid Test Cassette(Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>IHCV-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:34.805Z</lastUpdated>
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  <row>
    <udiDi>10608337000563</udiDi>
    <basicUdiDi>B-10608337000563</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 100 Count</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>1001-0274</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:42.392Z</lastUpdated>
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  <row>
    <udiDi>08693285187959</udiDi>
    <basicUdiDi>B-08693285187959</basicUdiDi>
    <tradeName>08693285187959</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC02340</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:27.137Z</lastUpdated>
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  <row>
    <udiDi>08693285187867</udiDi>
    <basicUdiDi>B-08693285187867</basicUdiDi>
    <tradeName>08693285187867</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC02205</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:06.276Z</lastUpdated>
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  <row>
    <udiDi>08693285187843</udiDi>
    <basicUdiDi>B-08693285187843</basicUdiDi>
    <tradeName>08693285187843</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC02220</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:02.272Z</lastUpdated>
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  <row>
    <udiDi>08693285187836</udiDi>
    <basicUdiDi>B-08693285187836</basicUdiDi>
    <tradeName>08693285187836</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC02140</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:01.492Z</lastUpdated>
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  <row>
    <udiDi>08693285186716</udiDi>
    <basicUdiDi>B-08693285186716</basicUdiDi>
    <tradeName>08693285186716</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:34.195Z</lastUpdated>
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  <row>
    <udiDi>08693285186709</udiDi>
    <basicUdiDi>B-08693285186709</basicUdiDi>
    <tradeName>08693285186709</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>TIHC01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:33.795Z</lastUpdated>
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  <row>
    <udiDi>08693285182787</udiDi>
    <basicUdiDi>B-08693285182787</basicUdiDi>
    <tradeName>08693285182787</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>IHC02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:29:37.841Z</lastUpdated>
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  <row>
    <udiDi>08693285182701</udiDi>
    <basicUdiDi>B-08693285182701</basicUdiDi>
    <tradeName>08693285182701</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RTHC02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:29:26.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285182626</udiDi>
    <basicUdiDi>B-08693285182626</basicUdiDi>
    <tradeName>08693285182626</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>THC02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:27:50.052Z</lastUpdated>
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    <udiDi>08693285181292</udiDi>
    <basicUdiDi>B-08693285181292</basicUdiDi>
    <tradeName>08693285181292</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>IHC01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:26:09.743Z</lastUpdated>
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    <udiDi>08693285181179</udiDi>
    <basicUdiDi>B-08693285181179</basicUdiDi>
    <tradeName>08693285181179</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RTHC01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:56.129Z</lastUpdated>
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    <udiDi>08693285181056</udiDi>
    <basicUdiDi>B-08693285181056</basicUdiDi>
    <tradeName>08693285181056</tradeName>
    <deviceName>Anti-HCV Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>THC01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:37.745Z</lastUpdated>
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    <udiDi>00816490028482</udiDi>
    <basicUdiDi>B-00816490028482</basicUdiDi>
    <tradeName>HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)</tradeName>
    <deviceName>HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>GCHCV-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:51.786Z</lastUpdated>
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    <udiDi>00816490028475</udiDi>
    <basicUdiDi>B-00816490028475</basicUdiDi>
    <tradeName>HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)</tradeName>
    <deviceName>HCV Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma)(Cassette)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>GCHCV-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:50.197Z</lastUpdated>
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  <row>
    <udiDi>00628347560973</udiDi>
    <basicUdiDi>B-00628347560973</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 Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-06-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:28.589Z</lastUpdated>
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</eudamedExport>