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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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T21:54:41.487Z</lastUpdated>
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    <tradeName>MAGLUMI Human Parainfluenza Virus IgM (CLIA)</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
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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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>MAGLUMI Legionella pneumophila IgM (CLIA)</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219022M</reference>
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    <lastUpdated>2026-07-01T21:54:41.375Z</lastUpdated>
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    <udiDi>06947145547592</udiDi>
    <basicUdiDi>69471455276WJ</basicUdiDi>
    <tradeName>MAGLUMI Legionella pneumophila 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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130619022M</reference>
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    <lastUpdated>2026-07-01T21:54:41.348Z</lastUpdated>
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    <udiDi>06947145547646</udiDi>
    <basicUdiDi>69471455277WL</basicUdiDi>
    <tradeName>MAGLUMI Respiratory Syncytial 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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130219019M</reference>
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    <lastUpdated>2026-07-01T21:54:25.365Z</lastUpdated>
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    <tradeName>MAGLUMI Respiratory Syncytial 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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:25.351Z</lastUpdated>
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    <udiDi>06947145547721</udiDi>
    <basicUdiDi>69471455278WN</basicUdiDi>
    <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>
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    <lastUpdated>2026-07-01T21:54:25.315Z</lastUpdated>
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    <basicUdiDi>69471455278WN</basicUdiDi>
    <tradeName>MAGLUMI Adenovirus 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>
    <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>130219020M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:25.300Z</lastUpdated>
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    <udiDi>06947145547820</udiDi>
    <basicUdiDi>69471455279WQ</basicUdiDi>
    <tradeName>MAGLUMI Coxsackievirus B 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>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201279MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:25.271Z</lastUpdated>
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    <udiDi>06947145547837</udiDi>
    <basicUdiDi>69471455279WQ</basicUdiDi>
    <tradeName>MAGLUMI Coxsackievirus B 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>
    <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>130219021M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:25.257Z</lastUpdated>
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    <udiDi>06947145565183</udiDi>
    <basicUdiDi>694714551023HQ</basicUdiDi>
    <tradeName>MAGLUMI Fibrin/fibrinogen degradation products (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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130218005M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:24.962Z</lastUpdated>
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    <udiDi>06947145565190</udiDi>
    <basicUdiDi>694714551023HQ</basicUdiDi>
    <tradeName>MAGLUMI Fibrin/fibrinogen degradation products (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>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011023MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:24.946Z</lastUpdated>
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    <udiDi>06947145565329</udiDi>
    <basicUdiDi>69471455401VV</basicUdiDi>
    <tradeName>MAGLUMI Dengue virus NS1 Antigen (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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201401MT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:54:24.917Z</lastUpdated>
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    <udiDi>06947145558826</udiDi>
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    <tradeName>Hemolumi Sample Diluent</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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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HAEMOSTASIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130104001NSN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:46:57.957Z</lastUpdated>
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    <tradeName>Hemolumi Sample Diluent</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>
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    <lastUpdated>2026-07-01T19:46:39.095Z</lastUpdated>
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    <tradeName>Hemolumi Sample Diluent</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>HAEMOSTASIS REAGENTS - OTHER</emdnDescription>
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    <tradeName>Hemolumi Sample Diluent</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>HAEMOSTASIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130104002NWF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:46:39.049Z</lastUpdated>
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    <udiDi>06947145546953</udiDi>
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    <tradeName>Centrifuge Module</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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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060102</emdnCode>
    <emdnDescription>AUTOMATED SAMPLE TRANSPORT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010103002201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:37.169Z</lastUpdated>
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    <tradeName>Decapper Module</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>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED SAMPLE TRANSPORT SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010103002301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:37.154Z</lastUpdated>
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