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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>
    <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>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:21:19.128Z</lastUpdated>
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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>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <tradeName>Heart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Total Triiodothyronine 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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    <reference>2×50 test</reference>
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    <tradeName>Heart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Total Triiodothyronine 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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    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:21:08.328Z</lastUpdated>
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    <tradeName>B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>B-type natriuretic 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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <tradeName>B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>B-type natriuretic peptide 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>
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    <tradeName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide 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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    <tradeName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:58.719Z</lastUpdated>
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    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:57.516Z</lastUpdated>
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    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:56.319Z</lastUpdated>
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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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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:49.106Z</lastUpdated>
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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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    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:47.915Z</lastUpdated>
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    <tradeName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <tradeName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <tradeName>Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Alpha-Fetoprotein Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:20:39.500Z</lastUpdated>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
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    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
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