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    <tradeName>Inﬂuenza B Antigen Rapid Test</tradeName>
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    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <reference>RINb-80225</reference>
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    <tradeName>Inﬂuenza B Antigen Rapid Test</tradeName>
    <deviceName>Inﬂuenza B Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <tradeName>Rotavirus Group A Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus Group A Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <tradeName>RSV Rapid Test</tradeName>
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    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>SARS-CoV-2 &amp; Inﬂuenza A/B Antigen Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2 &amp; Inﬂuenza A/B Antigen Combo Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRP-82220</reference>
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    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
    <deviceName>Zika IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>ZIKA VIRUS</emdnDescription>
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    <tradeName>Zika IgG/IgM Rapid Test</tradeName>
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    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>SARS-COV-2 Antigen Rapid Test Device</tradeName>
    <deviceName>SARS-COV-2 Antigen Rapid Test Device</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSA-8025</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
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    <tradeName>SARS-COV-2 Antigen Rapid Test Device</tradeName>
    <deviceName>SARS-COV-2 Antigen Rapid Test Device</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSA-8021</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:15.061Z</lastUpdated>
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    <tradeName>SARS-COV-2 Antigen Rapid Test Device</tradeName>
    <deviceName>SARS-COV-2 Antigen Rapid Test Device</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:14.261Z</lastUpdated>
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    <tradeName>Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)</tradeName>
    <deviceName>Monkeypox Virus (MPxV) Antigen Rapid Detection Kit (Colloidal Gold)</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>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPG290025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:48:54.816Z</lastUpdated>
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    <tradeName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</tradeName>
    <deviceName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</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>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPG021025-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:31:56.347Z</lastUpdated>
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    <basicUdiDi>B-06974521001867</basicUdiDi>
    <tradeName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</tradeName>
    <deviceName>ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:31:55.552Z</lastUpdated>
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    <tradeName>Diagnostic Kit for 2019-Novel Coronavirus(2019-nCoV) Ag Test (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Diagnostic Kit for 2019-Novel Coronavirus(2019-nCoV) Ag Test (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>SARS-CoV-2 Antigen Rapid Test Cassette</tradeName>
    <deviceName>SARS-CoV-2 Antigen  Rapid Test Cassette</deviceName>
    <manufacturerName>Merlin Biomedical (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021840</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP0271-1</reference>
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    <lastUpdated>2026-07-06T16:18:22.378Z</lastUpdated>
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    <tradeName>SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) Saliva Test</tradeName>
    <deviceName>SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) Saliva Test</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RQ013</reference>
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    <lastUpdated>2026-07-06T16:12:15.187Z</lastUpdated>
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    <tradeName>SARS-CoV-2 Virus Neutralization Test Kit (Colloidal gold method)</tradeName>
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    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
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    <tradeName>SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit(Colloidal gold method)</tradeName>
    <deviceName>SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
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    <reference>RQ005</reference>
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    <tradeName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Dengue NS1 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR022</reference>
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    <lastUpdated>2026-07-06T16:11:55.985Z</lastUpdated>
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    <tradeName>SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method) Saliva Test lollopop style</tradeName>
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    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <reference>RQ012</reference>
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    <lastUpdated>2026-07-06T16:11:36.856Z</lastUpdated>
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