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    <deviceName>Anti-Sm/RNP IgG (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T07:51:22.291Z</lastUpdated>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <tradeName>MAGLUMI Anti-Centromeres IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-Centromeres IgG (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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    <tradeName>MAGLUMI Anti-Scl-70 IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-Scl-70 IgG (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <tradeName>MAGLUMI Anti-Ro-52 IgG (CLIA) Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <tradeName>MAGLUMI Anti-PM-Scl IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-PM-Scl IgG (CLIA) Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06947145565077</udiDi>
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    <tradeName>MAGLUMI Anti-Nucleosomes IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-Nucleosomes IgG (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>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602011020MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:48:08.139Z</lastUpdated>
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    <udiDi>06973880815382</udiDi>
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    <tradeName>Sp100 IgG Control</tradeName>
    <deviceName>Sp100 IgG Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZCC116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:10:05.482Z</lastUpdated>
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    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4498268</reference>
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    <lastUpdated>2026-06-28T05:47:26.429Z</lastUpdated>
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    <lastUpdated>2026-06-28T05:47:25.229Z</lastUpdated>
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    <deviceName>Rheumatoid Control Plus</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-28T05:37:50.070Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-28T05:37:48.873Z</lastUpdated>
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    <lastUpdated>2026-06-28T05:37:39.277Z</lastUpdated>
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    <tradeName>ADVIA Centaur  aTgII Quality Control (aTgII QC)</tradeName>
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