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    <deviceName>Lipoprotein-associated Phospholipase A2 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <tradeName>Lipoprotein-associated Phospholipase A2 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <tradeName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Creatine Kinase MB Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
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    <tradeName>Pro-gastrin-releasing peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
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    <tradeName>Pro-gastrin-releasing peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <tradeName>Pro-gastrin-releasing peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Pro-gastrin-releasing peptide Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>PRO-GASTRIN-RELEASING PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:28:34.313Z</lastUpdated>
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    <tradeName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030108</emdnCode>
    <emdnDescription>CANCER ANTIGEN 242</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:28:33.111Z</lastUpdated>
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    <tradeName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <tradeName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Carbohydrate Antigen 242 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <tradeName>Carbohydrate Antigen 50 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Carbohydrate Antigen 50 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <deviceName>Carbohydrate Antigen 50 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceName>Carbohydrate Antigen 50 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
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    <deviceName>Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceName>Carbohydrate Antigen 19-9 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <deviceName>Cancer Antigen 72-4 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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