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    <basicUdiDi>B-06973841000987</basicUdiDi>
    <tradeName>Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Heart Type Fatty Acid Binding Protein Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0200</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:08.855Z</lastUpdated>
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    <udiDi>06978465237177</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:52.847Z</lastUpdated>
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    <udiDi>06978465237160</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:51.650Z</lastUpdated>
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    <udiDi>06978465237153</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:45.646Z</lastUpdated>
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    <udiDi>06978465232707</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:21:09.521Z</lastUpdated>
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    <udiDi>06978465232653</udiDi>
    <basicUdiDi>697846523ProteinC15RQ</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160705</emdnCode>
    <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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    <udiDi>06952804802479</udiDi>
    <basicUdiDi>B-06952804802479</basicUdiDi>
    <tradeName>Heart Fatty Acid Bindingprotein Chemiluminescence  Immunoassay Test Kit</tradeName>
    <deviceName>Heart Fatty Acid Bindingprotein Chemiluminescence  Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160705</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID-BINDING PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G103A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:56.471Z</lastUpdated>
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