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    <tradeName>Free Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <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>Total Thyroxine Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <emdnDescription>THYROXINE</emdnDescription>
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    <tradeName>Free Thyroxine Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <basicUdiDi>697846523HormoneB06HZ</basicUdiDi>
    <tradeName>Thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>THYROGLOBULIN</emdnDescription>
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    <basicUdiDi>697846523autoAbsB01QN</basicUdiDi>
    <tradeName>Antibody to thyroglobulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <basicUdiDi>697846523autoAbsB02QQ</basicUdiDi>
    <tradeName>Antibodies to Thyroid Peroxidase Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697846523HormoneB17J6</basicUdiDi>
    <tradeName>Insulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <emdnDescription>INSULIN</emdnDescription>
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    <tradeName>C-Peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <basicUdiDi>697846523VitaminB02LD</basicUdiDi>
    <tradeName>Vitamin B12 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></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>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <lastUpdated>2026-06-16T08:39:05.250Z</lastUpdated>
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    <basicUdiDi>697846523LipidsB01WN</basicUdiDi>
    <tradeName>Folate Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <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>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <basicUdiDi>697846523HormoneB07J3</basicUdiDi>
    <tradeName>Parathyroid Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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    <basicUdiDi>697846523ProteinB01R8</basicUdiDi>
    <tradeName>Calcitonin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697846523ProteinB02RA</basicUdiDi>
    <tradeName>Ferritin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <basicUdiDi>697846523ProteinB03RC</basicUdiDi>
    <tradeName>Procalcitonin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Interleukin-6 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
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    <basicUdiDi>697846523ProteinB04RE</basicUdiDi>
    <tradeName>Serum Amyloid A protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
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    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
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    <basicUdiDi>697846523ProteinB05RG</basicUdiDi>
    <tradeName>Pepsinogen I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697846523ProteinB06RJ</basicUdiDi>
    <tradeName>Pepsinogen II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>697846523ProteinB07RL</basicUdiDi>
    <tradeName>Gastrin-17 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
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