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    <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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    <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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    <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>
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    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
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    <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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    <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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    <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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    <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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    <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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    <udiDi>08595696304348</udiDi>
    <basicUdiDi>B-08595696304348</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Hepatitis C Virus (HCV) Diagnostic PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>A58427</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:36.773Z</lastUpdated>
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    <udiDi>08594161956914</udiDi>
    <basicUdiDi>B-08594161956914</basicUdiDi>
    <tradeName>GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>HCVD/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:46.503Z</lastUpdated>
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    <udiDi>08594161956891</udiDi>
    <basicUdiDi>B-08594161956891</basicUdiDi>
    <tradeName>GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</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>HCVD/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:44.904Z</lastUpdated>
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    <udiDi>06955792731141</udiDi>
    <basicUdiDi>B-06955792731141</basicUdiDi>
    <tradeName>Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit  (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit  (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>S3119E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:10.537Z</lastUpdated>
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    <udiDi>06955792731127</udiDi>
    <basicUdiDi>B-06955792731127</basicUdiDi>
    <tradeName>Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3034E</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:07.526Z</lastUpdated>
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    <udiDi>04262353370032</udiDi>
    <basicUdiDi>B-04262353370032</basicUdiDi>
    <tradeName>PoET HCV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020307</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2A-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:12.685Z</lastUpdated>
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