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    <tradeName>Imagemate CT-Pro Hose Tubing System</tradeName>
    <deviceName>Imagemate CT-Pro Hose Tubing System</deviceName>
    <manufacturerName>Suzhou Hengrui Hongyuan Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044883</manufacturerSrn>
    <authorisedRepresentativeName>PureCE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006069</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039085</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ImageCT-325-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:17:15.648Z</lastUpdated>
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    <tradeName>Imagemate CT-Pro Injection System</tradeName>
    <deviceName>Imagemate CT-Pro Injection System</deviceName>
    <manufacturerName>Suzhou Hengrui Hongyuan Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044883</manufacturerSrn>
    <authorisedRepresentativeName>PureCE B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ImageMate CT-pro E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:17:14.866Z</lastUpdated>
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    <tradeName>Imagemate CT-Pro Injection System</tradeName>
    <deviceName>Imagemate CT-pro Injection System</deviceName>
    <manufacturerName>Suzhou Hengrui Hongyuan Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044883</manufacturerSrn>
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    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ImageMate CT-pro S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:17:14.067Z</lastUpdated>
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    <tradeName>Imagemate CT-Pro Injection System</tradeName>
    <deviceName>Imagemate CT-Pro Injection System</deviceName>
    <manufacturerName>Suzhou Hengrui Hongyuan Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044883</manufacturerSrn>
    <authorisedRepresentativeName>PureCE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006069</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ImageMate CT-pro M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:17:10.044Z</lastUpdated>
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