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    <basicUdiDi>B-06974674891490</basicUdiDi>
    <tradeName>SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method)</tradeName>
    <deviceName>SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0130</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:19.044Z</lastUpdated>
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    <udiDi>06974674891452</udiDi>
    <basicUdiDi>B-06974674891452</basicUdiDi>
    <tradeName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</tradeName>
    <deviceName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:17.442Z</lastUpdated>
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    <udiDi>06974674891445</udiDi>
    <basicUdiDi>B-06974674891445</basicUdiDi>
    <tradeName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</tradeName>
    <deviceName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:16.645Z</lastUpdated>
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    <udiDi>06974674891438</udiDi>
    <basicUdiDi>B-06974674891438</basicUdiDi>
    <tradeName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</tradeName>
    <deviceName>Flu A &amp; Flu B Antigen Rapid Detection Kit (Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0029</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:15.042Z</lastUpdated>
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    <udiDi>06974674891391</udiDi>
    <basicUdiDi>B-06974674891391</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:08.637Z</lastUpdated>
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    <udiDi>06974674891384</udiDi>
    <basicUdiDi>B-06974674891384</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0024</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:06.239Z</lastUpdated>
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    <udiDi>06974674891377</udiDi>
    <basicUdiDi>B-06974674891377</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:04.631Z</lastUpdated>
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    <udiDi>06974674890813</udiDi>
    <basicUdiDi>B-06974674890813</basicUdiDi>
    <tradeName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</tradeName>
    <deviceName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:55.831Z</lastUpdated>
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    <udiDi>06974674890820</udiDi>
    <basicUdiDi>B-06974674890820</basicUdiDi>
    <tradeName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</tradeName>
    <deviceName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:53.430Z</lastUpdated>
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    <udiDi>06974674890806</udiDi>
    <basicUdiDi>B-06974674890806</basicUdiDi>
    <tradeName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</tradeName>
    <deviceName>SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:51.037Z</lastUpdated>
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    <udiDi>06974541565639</udiDi>
    <basicUdiDi>B-06974541565639</basicUdiDi>
    <tradeName>06974541565639</tradeName>
    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2114-11</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:01.446Z</lastUpdated>
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    <udiDi>06974541565622</udiDi>
    <basicUdiDi>B-06974541565622</basicUdiDi>
    <tradeName>06974541565622</tradeName>
    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/MP Antigen Rapid Test Kit</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2114-11</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:59.845Z</lastUpdated>
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    <udiDi>06974541565615</udiDi>
    <basicUdiDi>B-06974541565615</basicUdiDi>
    <tradeName>06974541565615</tradeName>
    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2508</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:57.443Z</lastUpdated>
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    <udiDi>06974541565608</udiDi>
    <basicUdiDi>B-06974541565608</basicUdiDi>
    <tradeName>06974541565608</tradeName>
    <deviceName>SARS-CoV-2/Flu A/Flu B/RSV/ADV/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2508</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:55.835Z</lastUpdated>
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    <udiDi>06974541565561</udiDi>
    <basicUdiDi>B-06974541565561</basicUdiDi>
    <tradeName>06974541565561</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2521</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:55.039Z</lastUpdated>
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    <udiDi>06974541565578</udiDi>
    <basicUdiDi>B-06974541565578</basicUdiDi>
    <tradeName>06974541565578</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2521</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:53.439Z</lastUpdated>
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    <udiDi>06974541565530</udiDi>
    <basicUdiDi>B-06974541565530</basicUdiDi>
    <tradeName>06974541565530</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:51.030Z</lastUpdated>
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    <udiDi>06974541565554</udiDi>
    <basicUdiDi>B-06974541565554</basicUdiDi>
    <tradeName>06974541565554</tradeName>
    <deviceName>SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICA2501</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:49.570Z</lastUpdated>
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    <udiDi>06974521005988</udiDi>
    <basicUdiDi>B-06974521005988</basicUdiDi>
    <tradeName>Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）</tradeName>
    <deviceName>Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPL031025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:43:11.611Z</lastUpdated>
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    <udiDi>06974521005698</udiDi>
    <basicUdiDi>B-06974521005698</basicUdiDi>
    <tradeName>Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPF062025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:43:10.816Z</lastUpdated>
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