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<eudamedExport entity="devices">
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    <udiDi>08683548259691</udiDi>
    <basicUdiDi>B-08683548259691</basicUdiDi>
    <tradeName>LyoSens HEV Detection qPCR Kit</tradeName>
    <deviceName>HEV 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>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:58.921Z</lastUpdated>
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  <row>
    <udiDi>08683548257727</udiDi>
    <basicUdiDi>B-08683548257727</basicUdiDi>
    <tradeName>ChainFor HDV Detection qPCR Kit</tradeName>
    <deviceName>HDV 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>W0105020406</emdnCode>
    <emdnDescription>HEPATITIS DELTA VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP72</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:16:51.962Z</lastUpdated>
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    <udiDi>08683548257703</udiDi>
    <basicUdiDi>B-08683548257703</basicUdiDi>
    <tradeName>ChainFor HEV Detection qPCR Kit</tradeName>
    <deviceName>HEV 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>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP70</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:16:51.176Z</lastUpdated>
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    <udiDi>08683548255655</udiDi>
    <basicUdiDi>B-08683548255655</basicUdiDi>
    <tradeName>RapidFor™ HEV IgM Rapid Test Kit</tradeName>
    <deviceName>HEV IgM Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:43.418Z</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>08595696304331</udiDi>
    <basicUdiDi>B-08595696304331</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis B Virus (HBV) 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58426</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:35.965Z</lastUpdated>
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  <row>
    <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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  <row>
    <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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  <row>
    <udiDi>08594161952039</udiDi>
    <basicUdiDi>B-08594161952039</basicUdiDi>
    <tradeName>GeneProof Hepatitis B Virus (HBV) PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis B Virus (HBV) 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBV/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:08.864Z</lastUpdated>
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  <row>
    <udiDi>08594161952015</udiDi>
    <basicUdiDi>B-08594161952015</basicUdiDi>
    <tradeName>GeneProof Hepatitis B Virus (HBV) PCR Kit</tradeName>
    <deviceName>GeneProof Hepatitis B Virus (HBV) 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>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBV/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:08.063Z</lastUpdated>
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  <row>
    <udiDi>08050616040183</udiDi>
    <basicUdiDi>B-08050616040183</basicUdiDi>
    <tradeName>HEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVM.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:10:18.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903343227</udiDi>
    <basicUdiDi>B-06977903343227</basicUdiDi>
    <tradeName>06977903343227</tradeName>
    <deviceName>HAV IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110236C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:33:01.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977903343210</udiDi>
    <basicUdiDi>B-06977903343210</basicUdiDi>
    <tradeName>06977903343210</tradeName>
    <deviceName>HAV IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110236C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:59.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753476024</udiDi>
    <basicUdiDi>B-06976753476024</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Device(Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A531401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:53.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976753475935</udiDi>
    <basicUdiDi>B-06976753475935</basicUdiDi>
    <tradeName>HCV Rapid Test Device (Serum/Plasma/Whole blood)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020301</emdnCode>
    <emdnDescription>HCV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A510501D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:33.127Z</lastUpdated>
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  <row>
    <udiDi>06976753475591</udiDi>
    <basicUdiDi>B-06976753475591</basicUdiDi>
    <tradeName>HEV IgM Rapid Test Device (Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020501</emdnCode>
    <emdnDescription>HEV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A401401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:17.914Z</lastUpdated>
  </row>
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    <udiDi>06976753474815</udiDi>
    <basicUdiDi>B-06976753474815</basicUdiDi>
    <tradeName>HAV IgGIgM Rapid Test Device(Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020199</emdnCode>
    <emdnDescription>HAV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A341401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:22.633Z</lastUpdated>
  </row>
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    <udiDi>06976202763309</udiDi>
    <basicUdiDi>B-06976202763309</basicUdiDi>
    <tradeName>HEV IgG/IgM Rapid Test</tradeName>
    <deviceName>HEV IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHEV-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:36.146Z</lastUpdated>
  </row>
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    <udiDi>06976202762623</udiDi>
    <basicUdiDi>B-06976202762623</basicUdiDi>
    <tradeName>HAV IgM Rapid Test</tradeName>
    <deviceName>HAV IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVm-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:50.434Z</lastUpdated>
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    <udiDi>06976202762616</udiDi>
    <basicUdiDi>B-06976202762616</basicUdiDi>
    <tradeName>HAV IgG/IgM Test</tradeName>
    <deviceName>HAV IgG/IgM Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVb-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:34.366Z</lastUpdated>
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