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    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <lastUpdated>2026-07-06T17:52:29.848Z</lastUpdated>
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    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <tradeName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</tradeName>
    <deviceName>Monkeypox Virus Nucleic Acid Detection Kit (Enzymatic Probe Isothermal Amplification)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
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    <deviceName>Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
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    <tradeName>06974795550641</tradeName>
    <deviceName>Nipah Virus Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE CHIKV/YFV/DENV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE RSV&amp;MP&amp;ADV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE RSV&amp;MP&amp;ADV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018026305-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:16.774Z</lastUpdated>
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    <basicUdiDi>B-06974767392071</basicUdiDi>
    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Dengue virus type III/IV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018033402-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:15.996Z</lastUpdated>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Dengue virus type I/II Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnCode>W0105040511</emdnCode>
    <emdnDescription>DENGUE VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018033202-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:42:11.961Z</lastUpdated>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Enterovirus 71 Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>ENTEROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018018605-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE SARS-CoV-2&amp;FluA&amp;FluB&amp;RSV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
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    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Norovirus GI/GII Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6018033002-CE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:41:59.155Z</lastUpdated>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE SARS-CoV-2&amp;FluA&amp;FluB&amp;RSV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Monkeypox Virus Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE Monkeypox Virus Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™LyocartE FluA&amp;FluB&amp;RSV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE SARS-CoV-2 Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024155</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>FlashDetect</tradeName>
    <deviceName>FlashDetect™ LyocartE SARS-CoV-2 Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
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    <tradeName>06974767390312</tradeName>
    <deviceName>FlashDetect™ LyocartE FluA&amp;FluB&amp;RSV Assay</deviceName>
    <manufacturerName>Coyote Bioscience Co., Ltd.</manufacturerName>
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    <reference>6018011602-CE</reference>
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