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    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
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    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
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    <deviceName>Anti-Cardiolipin Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
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    <basicUdiDi>697388081012NP</basicUdiDi>
    <tradeName>Cardiolipin IgM Control</tradeName>
    <deviceName>Cardiolipin IgM Control</deviceName>
    <manufacturerName>SHENZHEN EVER-BLUE BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000025048</manufacturerSrn>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>06947145583910</udiDi>
    <basicUdiDi>69471455442WB</basicUdiDi>
    <tradeName>MAGLUMI Anti-β2-Glycoprotein 1 (CLIA) Controls</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 (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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:54:03.377Z</lastUpdated>
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    <udiDi>06947145583873</udiDi>
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    <tradeName>MAGLUMI Anti-Cardiolipin (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin (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-Cardiolipin IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin IgA (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-β2-Glycoprotein 1 IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgA (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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201439MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:55.358Z</lastUpdated>
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    <udiDi>06947145565039</udiDi>
    <basicUdiDi>69471455446WK</basicUdiDi>
    <tradeName>MAGLUMI Anti-DGP IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-DGP 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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201446MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:49.752Z</lastUpdated>
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    <udiDi>06947145564919</udiDi>
    <basicUdiDi>69471455443WD</basicUdiDi>
    <tradeName>MAGLUMI Anti-tissue Transglutaminase IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-tissue Transglutaminase IgA (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>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201443MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:45.746Z</lastUpdated>
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    <udiDi>06947145564995</udiDi>
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    <tradeName>MAGLUMI Anti-DGP IgA (CLIA) Controls</tradeName>
    <deviceName>Anti-DGP IgA (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>
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    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201445MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:43.336Z</lastUpdated>
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    <udiDi>06947145564957</udiDi>
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    <tradeName>MAGLUMI Anti-tissue Transglutaminase IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-tissue Transglutaminase 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>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160201444MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:42.530Z</lastUpdated>
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    <udiDi>06947145540500</udiDi>
    <basicUdiDi>69471455268WK</basicUdiDi>
    <tradeName>MAGLUMI Anti-GBM IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-GBM 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>160201268MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:04.062Z</lastUpdated>
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    <udiDi>06947145540463</udiDi>
    <basicUdiDi>69471455185WE</basicUdiDi>
    <tradeName>MAGLUMI Anti-PR3 IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-PR3 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>
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    <reference>160201185MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:53:03.292Z</lastUpdated>
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    <udiDi>06947145540364</udiDi>
    <basicUdiDi>69471455437WJ</basicUdiDi>
    <tradeName>MAGLUMI Anti-Cardiolipin IgM (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin IgM (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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    <reference>160201437MT</reference>
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    <lastUpdated>2026-07-02T07:53:02.460Z</lastUpdated>
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    <tradeName>MAGLUMI Anti-Cardiolipin IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-Cardiolipin 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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:58.562Z</lastUpdated>
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    <basicUdiDi>69471455441W9</basicUdiDi>
    <tradeName>MAGLUMI Anti-β2-Glycoprotein 1 IgM (CLIA) Controls</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 IgM (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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:56.880Z</lastUpdated>
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    <tradeName>MAGLUMI Anti-β2-Glycoprotein 1 IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-β2-Glycoprotein 1 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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <reference>160201440MT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:52:56.075Z</lastUpdated>
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    <tradeName>MAGLUMI Anti-MPO IgG (CLIA) Controls</tradeName>
    <deviceName>Anti-MPO 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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    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
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    <tradeName>MAGLUMI Anti-Jo-1 IgG (CLIA) Controls</tradeName>
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    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-07-02T07:51:43.179Z</lastUpdated>
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