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    <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>
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  <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>
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  <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>
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    <udiDi>07332940006433</udiDi>
    <basicUdiDi>B-07332940006433</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HCV VL Fingerstick</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHCV-FS-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:57.450Z</lastUpdated>
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  <row>
    <udiDi>07332940001544</udiDi>
    <basicUdiDi>B-07332940001544</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HCV Viral Load</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHCV-VL-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:17.939Z</lastUpdated>
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  <row>
    <udiDi>08905459006912</udiDi>
    <basicUdiDi>8905459MHCVRT9A</basicUdiDi>
    <tradeName>08905459006912</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>W0105020308</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) ANTIGEN/ANTIBODY COMBO TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHCV-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:52:35.754Z</lastUpdated>
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  <row>
    <udiDi>08033629924589</udiDi>
    <basicUdiDi>803362992GENHCVD6</basicUdiDi>
    <tradeName>08033629924589</tradeName>
    <deviceName>GEN-C 3.0</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020309</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC004/24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:47:05.860Z</lastUpdated>
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  <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>
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    <udiDi>08698898740027</udiDi>
    <basicUdiDi>B-08698898740027</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion HCV QNP 2.1 Real-Time PCR</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0020202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:53.246Z</lastUpdated>
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  <row>
    <udiDi>08684595034910</udiDi>
    <basicUdiDi>B-08684595034910</basicUdiDi>
    <tradeName>LyoSens HCV Detection qPCR Kit</tradeName>
    <deviceName>HCV Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020399</emdnCode>
    <emdnDescription>HCV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO79</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:06.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215091</udiDi>
    <basicUdiDi>B-08684387215091</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201923-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:51.947Z</lastUpdated>
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  <row>
    <udiDi>08684387215084</udiDi>
    <basicUdiDi>B-08684387215084</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201923-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:47.961Z</lastUpdated>
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  <row>
    <udiDi>08684387215077</udiDi>
    <basicUdiDi>B-08684387215077</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201923-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:47.146Z</lastUpdated>
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    <udiDi>08684387215060</udiDi>
    <basicUdiDi>B-08684387215060</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201923-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:46.352Z</lastUpdated>
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  <row>
    <udiDi>08684387212151</udiDi>
    <basicUdiDi>B-08684387212151</basicUdiDi>
    <tradeName>RevoDx HCV Genotyping qPCR Kit v01</tradeName>
    <deviceName>RevoDx HCV Genotyping qPCR Kit v01</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020309</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202325-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:45.886Z</lastUpdated>
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    <udiDi>08684387212144</udiDi>
    <basicUdiDi>B-08684387212144</basicUdiDi>
    <tradeName>RevoDx HCV Genotyping qPCR Kit v01</tradeName>
    <deviceName>RevoDx HCV Genotyping qPCR Kit v01</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020309</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202325-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:45.076Z</lastUpdated>
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    <udiDi>08684387212038</udiDi>
    <basicUdiDi>B-08684387212038</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:15.397Z</lastUpdated>
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    <udiDi>08684387212021</udiDi>
    <basicUdiDi>B-08684387212021</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:11.405Z</lastUpdated>
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    <udiDi>08684387212014</udiDi>
    <basicUdiDi>B-08684387212014</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:10.597Z</lastUpdated>
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    <udiDi>08684387212007</udiDi>
    <basicUdiDi>B-08684387212007</basicUdiDi>
    <tradeName>RevoDx HCV qPCR Kit</tradeName>
    <deviceName>RevoDx HCV qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:09.802Z</lastUpdated>
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