<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-A24291TY</udiDi>
    <basicUdiDi>B-A24291TY</basicUdiDi>
    <tradeName>Access HBs Ag</tradeName>
    <deviceName>Access HBs Ag</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A24291</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:15:38.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34240FZ</udiDi>
    <basicUdiDi>B-34240FZ</basicUdiDi>
    <tradeName>Access HBc Ab</tradeName>
    <deviceName>Access HBc Ab</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020202</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:35.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34210FQ</udiDi>
    <basicUdiDi>B-34210FQ</basicUdiDi>
    <tradeName>Access HAV IgM (Reagent Pack)</tradeName>
    <deviceName>Access HAV IgM (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34210</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:30.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34200FM</udiDi>
    <basicUdiDi>B-34200FM</basicUdiDi>
    <tradeName>HAV Ab (Reagent pack)</tradeName>
    <deviceName>HAV Ab (Reagent pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:24.748Z</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>08698898740621</udiDi>
    <basicUdiDi>B-08698898740621</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion HDV QNP 1.0 Real-Time PCR Kit</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>W0105020406</emdnCode>
    <emdnDescription>HEPATITIS DELTA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0060202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:00:01.242Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>08698898740010</udiDi>
    <basicUdiDi>B-08698898740010</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion HBV QNP 2.0 Real-Time PCR Kit</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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0010202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:49.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616282</udiDi>
    <basicUdiDi>B-08697962616282</basicUdiDi>
    <tradeName>SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020503</emdnCode>
    <emdnDescription>HEV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFHEV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:47.987Z</lastUpdated>
  </row>
  <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>08684595034897</udiDi>
    <basicUdiDi>B-08684595034897</basicUdiDi>
    <tradeName>LyoSens HBV Detection qPCR Kit</tradeName>
    <deviceName>HBV 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>W0105020299</emdnCode>
    <emdnDescription>HBV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO78</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:05.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030233</udiDi>
    <basicUdiDi>B-08684595030233</basicUdiDi>
    <tradeName>RapidFor™ HBsAb Rapid Test Kit (FIA)</tradeName>
    <deviceName>HBsAb Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020217</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN - QUANTITATIVE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO88</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:09.890Z</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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>08684387215053</udiDi>
    <basicUdiDi>B-08684387215053</basicUdiDi>
    <tradeName>RevoDx HBV qPCR Kit</tradeName>
    <deviceName>RevoDx HBV 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201922-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:45.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215046</udiDi>
    <basicUdiDi>B-08684387215046</basicUdiDi>
    <tradeName>RevoDx HBV qPCR Kit</tradeName>
    <deviceName>RevoDx HBV 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201922-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:41.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215039</udiDi>
    <basicUdiDi>B-08684387215039</basicUdiDi>
    <tradeName>RevoDx HBV qPCR Kit (Qualitative)</tradeName>
    <deviceName>RevoDx HBV 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201922-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:40.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215022</udiDi>
    <basicUdiDi>B-08684387215022</basicUdiDi>
    <tradeName>RevoDx HBV qPCR Kit</tradeName>
    <deviceName>RevoDx HBV 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201922-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:39.936Z</lastUpdated>
  </row>
</eudamedExport>