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    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <tradeName>KEYU Dry Chemistry Urine analysis Control</tradeName>
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    <tradeName>KEYU Urine Sediment Analyzer Quality Control</tradeName>
    <deviceName>Urine Sediment Analyzer Quality Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
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    <tradeName>KEYU Urine Sediment Analyzer Quality Control</tradeName>
    <deviceName>Urine Sediment Analyzer Quality Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <tradeName>KEYU Feces Formed Element Control</tradeName>
    <deviceName>Feces Formed Element Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <tradeName>KEYU Feces Formed Element Control</tradeName>
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    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <tradeName>KEYU Feces Formed Element Control</tradeName>
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    <tradeName>KEYU Feces Formed Element Control</tradeName>
    <deviceName>Feces Formed Element Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:50.376Z</lastUpdated>
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    <udiDi>06974735360163</udiDi>
    <basicUdiDi>B-06974735360163</basicUdiDi>
    <tradeName>KEYU Dry Chemistry Urine analysis Control</tradeName>
    <deviceName>Dry Chemistry Urine analysis Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>UNASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:26.364Z</lastUpdated>
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    <udiDi>06974735360149</udiDi>
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    <tradeName>KEYU Feces Formed Element Control</tradeName>
    <deviceName>Feces Formed Element Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T17:32:24.759Z</lastUpdated>
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    <deviceName>Glycated hemoglobin calibrator</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HbA1c</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:14.076Z</lastUpdated>
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    <deviceName>Electrolyte Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:02.064Z</lastUpdated>
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    <tradeName>Vaginitis Diagnosis Quality Control Kit</tradeName>
    <deviceName>Vaginitis Diagnosis Quality Control Kit</deviceName>
    <manufacturerName>Zhuhai Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026852</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>Blood Glucose Control Solutions</tradeName>
    <deviceName>Blood Glucose Control Solutions</deviceName>
    <manufacturerName>YASEE BioMedical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037011</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
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    <tradeName>Blood Glucose Control Solutions</tradeName>
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    <manufacturerName>YASEE BioMedical Inc.</manufacturerName>
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    <tradeName>HbA1c Calibrator</tradeName>
    <deviceName>HbA1c Calibrator</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBBZGH</reference>
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    <tradeName>A1c Go HbA1c Control</tradeName>
    <deviceName>A1c Go HbA1c Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>A1c Go HbA1c Control</tradeName>
    <deviceName>A1c Go HbA1c Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>HbA1c Calibrator</tradeName>
    <deviceName>HbA1c Calibrator</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBBZ072</reference>
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