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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
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    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
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    <lastUpdated>2026-07-06T23:19:11.592Z</lastUpdated>
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    <tradeName>06979355924863</tradeName>
    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:19:10.782Z</lastUpdated>
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    <udiDi>06978139071434</udiDi>
    <basicUdiDi>B-06978139071434</basicUdiDi>
    <tradeName>CA15-3 Test (FIA)</tradeName>
    <deviceName>CA15-3 Test (FIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320307102</reference>
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    <lastUpdated>2026-07-06T22:39:21.029Z</lastUpdated>
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    <tradeName>Cancer Antigen 15-3 (CA15-3) Determination Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA15-3) Determination Kit (Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Channel Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000053778</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR055EU01</reference>
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    <lastUpdated>2026-07-06T22:10:12.856Z</lastUpdated>
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    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KH019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:56:34.380Z</lastUpdated>
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    <tradeName>Cancer Antigen 15-3 (eCLIA)</tradeName>
    <deviceName>Cancer Antigen 15-3 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Cancer Antigen 15-3 (eCLIA)</tradeName>
    <deviceName>Cancer Antigen 15-3 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T21:18:50.484Z</lastUpdated>
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    <tradeName>Sharay CA15-3 (CLIA)</tradeName>
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    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <tradeName>Carbohydrate Antigen 153（CA153）Rapid Quantitative Test（Fluorescence immunoassay）</tradeName>
    <deviceName>Carbohydrate Antigen 153（CA153）Rapid Quantitative Test（Fluorescence immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
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    <tradeName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
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    <tradeName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
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    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
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    <tradeName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
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    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
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    <tradeName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Carbohydrate Antigen 15-3（CA15-3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1014-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:09:09.100Z</lastUpdated>
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