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<eudamedExport entity="devices">
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    <udiDi>D-ABT-IDT-A226UY</udiDi>
    <basicUdiDi>B-ABT-IDT-A226UY</basicUdiDi>
    <tradeName>Accu-Tell® HAV IgM/IgG Strip(Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® HAV IgM/IgG Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:05.586Z</lastUpdated>
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  <row>
    <udiDi>D-ABT-IDT-A218UZ</udiDi>
    <basicUdiDi>B-ABT-IDT-A218UZ</basicUdiDi>
    <tradeName>Accu-Tell® HAV IgM Strip (Serum/Plasma)</tradeName>
    <deviceName>Accu-Tell® HAV IgM Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-A218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:26:04.004Z</lastUpdated>
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  <row>
    <udiDi>86979834610375</udiDi>
    <basicUdiDi>B-86979834610375</basicUdiDi>
    <tradeName>Hepatitis E Test Device(Serum/plasma/whole blood)</tradeName>
    <deviceName>Hepatitis E Test Device(Serum/plasma/whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEPE241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:34.087Z</lastUpdated>
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  <row>
    <udiDi>86979834610351</udiDi>
    <basicUdiDi>B-86979834610351</basicUdiDi>
    <tradeName>Hepatitis A Test Device(Serum/plasma/whole blood)</tradeName>
    <deviceName>Hepatitis A Test Device(Serum/plasma/whole blood)</deviceName>
    <manufacturerName>Neo-nostics (Suzhou) Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013087</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEPA240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:22:32.494Z</lastUpdated>
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  <row>
    <udiDi>16972698601283</udiDi>
    <basicUdiDi>B-16972698601283</basicUdiDi>
    <tradeName>HEV IgM Rapid Test</tradeName>
    <deviceName>HEV IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:06.726Z</lastUpdated>
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  <row>
    <udiDi>16972698600156</udiDi>
    <basicUdiDi>B-16972698600156</basicUdiDi>
    <tradeName>HAV IgM Rapid Test</tradeName>
    <deviceName>HAV IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231103</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:42.735Z</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>08693285187966</udiDi>
    <basicUdiDi>B-08693285187966</basicUdiDi>
    <tradeName>08693285187966</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB04340</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:27.964Z</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>
  </row>
  <row>
    <udiDi>08693285187904</udiDi>
    <basicUdiDi>B-08693285187904</basicUdiDi>
    <tradeName>08693285187904</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB04205</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:08.671Z</lastUpdated>
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  <row>
    <udiDi>08693285187881</udiDi>
    <basicUdiDi>B-08693285187881</basicUdiDi>
    <tradeName>08693285187881</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB04220</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:07.877Z</lastUpdated>
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  <row>
    <udiDi>08693285187874</udiDi>
    <basicUdiDi>B-08693285187874</basicUdiDi>
    <tradeName>08693285187874</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB04140</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:07.079Z</lastUpdated>
  </row>
  <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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    <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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    <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>08693285186693</udiDi>
    <basicUdiDi>B-08693285186693</basicUdiDi>
    <tradeName>08693285186693</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB04</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:32.609Z</lastUpdated>
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    <udiDi>08693285186662</udiDi>
    <basicUdiDi>B-08693285186662</basicUdiDi>
    <tradeName>08693285186662</tradeName>
    <deviceName>Anti-HBs 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>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:28.430Z</lastUpdated>
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    <udiDi>08693285186686</udiDi>
    <basicUdiDi>B-08693285186686</basicUdiDi>
    <tradeName>08693285186686</tradeName>
    <deviceName>HBsAg 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>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TIHB03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:31:26.828Z</lastUpdated>
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</eudamedExport>