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    <deviceName>Pancreatic cancer associated protein Exosome Kit (immunostaining method)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
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    <deviceName>Pancreatic cancer associated protein Exosome Kit (immunostaining method)</deviceName>
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    <deviceName>Mycobacterium tuberculosis associated protein Exosome Kit (immunostaining method)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
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    <deviceName>Mycobacterium tuberculosis associated protein Exosome Kit (immunostaining method)</deviceName>
    <manufacturerName>Qingdao Raisecare Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033899</manufacturerSrn>
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    <tradeName>Human Epidermal GrowthFactor Receptor 2（HER-2）Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KA022</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
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    <tradeName>HOKAPI™ HER-2/NEU</tradeName>
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    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0102030301</emdnCode>
    <emdnDescription>HER-2/NEU</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010123601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:06:30.664Z</lastUpdated>
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