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    <basicUdiDi>697603340CE0016U</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CE001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:45.541Z</lastUpdated>
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    <udiDi>06976033400022</udiDi>
    <basicUdiDi>697603340TE003CT</basicUdiDi>
    <tradeName>High Throughput Automated Hemostasis Analyzer system</tradeName>
    <deviceName>High Throughput Automated Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:44.759Z</lastUpdated>
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    <udiDi>06976033400015</udiDi>
    <basicUdiDi>697603340TE002CR</basicUdiDi>
    <tradeName>Hemostasis Analyzer System</tradeName>
    <deviceName>Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:43.936Z</lastUpdated>
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    <udiDi>06976033400008</udiDi>
    <basicUdiDi>697603340TE001CP</basicUdiDi>
    <tradeName>Hemostasis Analyzer System</tradeName>
    <deviceName>Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:39.134Z</lastUpdated>
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