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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <basicUdiDi>84354402_MDXRESPB_ABR3Y</basicUdiDi>
    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ABR196TE</reference>
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    <udiDi>08435440217336</udiDi>
    <basicUdiDi>84354402_MDXRESPB_ABR3Y</basicUdiDi>
    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ABR101E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:52:55.022Z</lastUpdated>
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    <udiDi>08435440211822</udiDi>
    <basicUdiDi>84354402_MDXRESPB_ABR3Y</basicUdiDi>
    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ABR136E</reference>
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    <udiDi>08435440217343</udiDi>
    <basicUdiDi>84354402_MDXRESPB_ABR3Y</basicUdiDi>
    <tradeName>VIASURE Flu A, Flu B &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-ABR172E</reference>
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    <tradeName>LyoSens™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>LyoSens™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-24T19:50:33.045Z</lastUpdated>
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    <udiDi>08685115801401</udiDi>
    <basicUdiDi>0868511580PCR1125W</basicUdiDi>
    <tradeName>LyoSens™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO112WS96</reference>
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    <lastUpdated>2026-07-24T19:50:31.965Z</lastUpdated>
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    <udiDi>08684595032503</udiDi>
    <basicUdiDi>0868511580PCR1125W</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP112P50</reference>
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    <lastUpdated>2026-07-24T19:50:30.562Z</lastUpdated>
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    <udiDi>08435440216100</udiDi>
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    <tradeName>VIASURE SARS-CoV-2, Flu &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CFR101L</reference>
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    <lastUpdated>2026-07-24T19:49:17.881Z</lastUpdated>
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    <udiDi>08435440216117</udiDi>
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    <tradeName>VIASURE SARS-CoV-2, Flu &amp; RSV Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CFR101H</reference>
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    <lastUpdated>2026-07-24T19:49:17.708Z</lastUpdated>
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    <tradeName>LyoSens™</tradeName>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-24T19:49:12.976Z</lastUpdated>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO115WS48</reference>
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    <lastUpdated>2026-07-24T19:49:10.645Z</lastUpdated>
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    <tradeName>VIASURE SARS-CoV-2, Flu &amp; RSV Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CFR112L</reference>
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    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO115WS96</reference>
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    <lastUpdated>2026-07-24T19:49:00.765Z</lastUpdated>
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    <tradeName>VIASURE SARS-CoV-2, Flu &amp; RSV Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-CFR112H</reference>
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    <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>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP115P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:49:00.551Z</lastUpdated>
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