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    <tradeName>HEV RNA QUANTITATION (QT)</tradeName>
    <deviceName>HEV RNA QUANTITATION (QT)</deviceName>
    <manufacturerName>DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000029123</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEVONEQT.CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:52:23.224Z</lastUpdated>
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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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    <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>
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    <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>06974323010869</udiDi>
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    <tradeName>06974323010869</tradeName>
    <deviceName>Real-time PCR Detection Kit for Hepatitis E Virus</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:48.653Z</lastUpdated>
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    <udiDi>06974323010852</udiDi>
    <basicUdiDi>B-06974323010852</basicUdiDi>
    <tradeName>06974323010852</tradeName>
    <deviceName>Real-time PCR Detection Kit for Hepatitis E Virus</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:47.046Z</lastUpdated>
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    <udiDi>06971042229060</udiDi>
    <basicUdiDi>B-06971042229060</basicUdiDi>
    <tradeName>HEV General Type Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV General Type Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0307-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:19.272Z</lastUpdated>
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    <udiDi>06971042229053</udiDi>
    <basicUdiDi>B-06971042229053</basicUdiDi>
    <tradeName>HEV I &amp;III Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV I &amp;III Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0228-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:18.467Z</lastUpdated>
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    <udiDi>06971042229039</udiDi>
    <basicUdiDi>B-06971042229039</basicUdiDi>
    <tradeName>HEV Real Time RT-PCR Kit</tradeName>
    <deviceName>HEV Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0011-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:14.468Z</lastUpdated>
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    <udiDi>08685115805478</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>LyoSens  HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:36:28.641Z</lastUpdated>
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    <udiDi>08684595033456</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>ChainFor HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:30:09.871Z</lastUpdated>
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    <udiDi>04262353370087</udiDi>
    <basicUdiDi>B-04262353370087</basicUdiDi>
    <tradeName>PoET HEV</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2F-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:44:22.388Z</lastUpdated>
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