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    <deviceName>Mycoplasma Pneumoniae Antigen Combo Test Cassette: 1 Test/Kit</deviceName>
    <manufacturerName>Beijing Zhongjian Antai Diagnostic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052880</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:09.594Z</lastUpdated>
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    <udiDi>06973642383081</udiDi>
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    <deviceName>Tigsun COVID-19 Antigen Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <deviceName>Tigsun TORCH lgM/lgG Rapid Test</deviceName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
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    <deviceName>Tigsun TORCH lgM Rapid Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:51:55.455Z</lastUpdated>
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    <udiDi>06947145547806</udiDi>
    <basicUdiDi>69471455279WQ</basicUdiDi>
    <tradeName>MAGLUMI Coxsackievirus B IgM (CLIA)</tradeName>
    <deviceName>Coxsackievirus B IgM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619021M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:23.272Z</lastUpdated>
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    <udiDi>06947145547707</udiDi>
    <basicUdiDi>69471455278WN</basicUdiDi>
    <tradeName>MAGLUMI Adenovirus IgM (CLIA)</tradeName>
    <deviceName>Adenovirus IgM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619020M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:18.469Z</lastUpdated>
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    <udiDi>06947145547462</udiDi>
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    <tradeName>MAGLUMI Human Parainfluenza Virus IgM (CLIA)</tradeName>
    <deviceName>Human Parainfluenza Virus IgM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219025M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:12.161Z</lastUpdated>
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    <udiDi>06947145547301</udiDi>
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    <tradeName>MAGLUMI Influenza A Virus IgM (CLIA)</tradeName>
    <deviceName>Influenza A Virus IgM (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219023M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:09.682Z</lastUpdated>
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    <udiDi>06947145547349</udiDi>
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    <tradeName>MAGLUMI Influenza A Virus IgM (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619023M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:41.577Z</lastUpdated>
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    <tradeName>MAGLUMI Influenza A Virus IgM (CLIA) Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201273MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:41.554Z</lastUpdated>
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    <udiDi>06947145547509</udiDi>
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    <tradeName>MAGLUMI Human Parainfluenza Virus IgM (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619025M</reference>
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    <lastUpdated>2026-07-01T21:54:41.441Z</lastUpdated>
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    <tradeName>MAGLUMI Human Parainfluenza Virus IgM (CLIA) Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201275MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:41.417Z</lastUpdated>
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    <tradeName>MAGLUMI Adenovirus IgM (CLIA) Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201278MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:25.315Z</lastUpdated>
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    <udiDi>06947145547745</udiDi>
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    <tradeName>MAGLUMI Adenovirus IgM (CLIA)</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219020M</reference>
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    <lastUpdated>2026-07-01T21:54:25.300Z</lastUpdated>
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    <tradeName>MAGLUMI Coxsackievirus B IgM (CLIA) Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <reference>160201279MT</reference>
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    <lastUpdated>2026-07-01T21:54:25.271Z</lastUpdated>
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    <tradeName>MAGLUMI Coxsackievirus B IgM (CLIA)</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219021M</reference>
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    <lastUpdated>2026-07-01T21:54:25.257Z</lastUpdated>
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    <deviceName>RIDA®QUICK Norovirus</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP1404</reference>
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    <lastUpdated>2026-07-01T15:50:27.617Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>RIDASCREEN® Adenovirus</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:49:42.733Z</lastUpdated>
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