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    <tradeName>VIASURE SARS-CoV-2 Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <tradeName>AD Nucléis direct SARS-CoV-2_1-step RTCPR 48R</tradeName>
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    <manufacturerName>AD Nucleis</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
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    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:08:32.089Z</lastUpdated>
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    <tradeName>D-R209132K</tradeName>
    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
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    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:08:27.283Z</lastUpdated>
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    <deviceName>Novel CoronaVirus IgG Antibody  (2019-nCoV IgG) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:08:26.499Z</lastUpdated>
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    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
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    <tradeName>D-R208132E</tradeName>
    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>CORONAVIRUS IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-22T12:08:21.683Z</lastUpdated>
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    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
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    <emdnDescription>CORONAVIRUS IGM</emdnDescription>
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    <deviceName>Novel CoronaVirus IgM Antibody (2019-nCoV IgM)  Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
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    <deviceName>Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit</deviceName>
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    <deviceName>Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit (Fluorescence)</deviceName>
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