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    <tradeName>KEYU ParaSpin™ Intestinal Parasite Concentrator</tradeName>
    <deviceName>ParaSpin™ Intestinal Parasite Concentrator</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-F05-IV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:22:55.748Z</lastUpdated>
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    <basicUdiDi>697473536KUC22PN</basicUdiDi>
    <tradeName>KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova)</tradeName>
    <deviceName>ParaFloat™ Intestinal Parasite Concentrator (Ova)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-F05-II</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:22:54.947Z</lastUpdated>
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    <udiDi>06974735361801</udiDi>
    <basicUdiDi>697473536KUC21PL</basicUdiDi>
    <tradeName>KEYU ParaSpin™ Intestinal Parasite Concentrator</tradeName>
    <deviceName>ParaSpin™ Intestinal Parasite Concentrator</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-F05-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:22:54.147Z</lastUpdated>
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    <basicUdiDi>697473536KUC14PP</basicUdiDi>
    <tradeName>KEYU Cleaning Solution (FI)</tradeName>
    <deviceName>Cleaning Solution (FI)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-FW01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:32.415Z</lastUpdated>
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    <udiDi>06974735361498</udiDi>
    <basicUdiDi>697473536KUC15PR</basicUdiDi>
    <tradeName>KEYU Sample Collection Tube</tradeName>
    <deviceName>Sample Collection Tube</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-F03-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:28.413Z</lastUpdated>
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    <udiDi>06974735361481</udiDi>
    <basicUdiDi>697473536KUA09PL</basicUdiDi>
    <tradeName>KEYU Fluorescent Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescent Immunoassay Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-650S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:27.629Z</lastUpdated>
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    <udiDi>06974735361474</udiDi>
    <basicUdiDi>697473536KUC13PM</basicUdiDi>
    <tradeName>KEYU Iodine Solution</tradeName>
    <deviceName>Iodine Solution</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-FI01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:26.824Z</lastUpdated>
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    <tradeName>KEYU Sample Collection Tube</tradeName>
    <deviceName>Sample Collection Tube</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-U-12-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:26.011Z</lastUpdated>
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    <tradeName>KEYU Cleaning Solution C</tradeName>
    <deviceName>Cleaning Solution C</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-C01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:22.017Z</lastUpdated>
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    <udiDi>06974735361399</udiDi>
    <basicUdiDi>697473536KUC17PV</basicUdiDi>
    <tradeName>KEYU Diluent Solution C</tradeName>
    <deviceName>Diluent Solution C</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-D01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:21.226Z</lastUpdated>
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    <udiDi>06974735361115</udiDi>
    <basicUdiDi>697473536KUA06PE</basicUdiDi>
    <tradeName>KEYU Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescent Immunoassay Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:20.409Z</lastUpdated>
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    <udiDi>06974735360972</udiDi>
    <basicUdiDi>697473536KUC08PU</basicUdiDi>
    <tradeName>KEYU Urine Sample Collection Tube</tradeName>
    <deviceName>Urine Sample Collection Tube</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUBE-U-12-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:19.607Z</lastUpdated>
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    <udiDi>06974735360835</udiDi>
    <basicUdiDi>697473536KUC09PW</basicUdiDi>
    <tradeName>KEYU Concentrated Cleaning Solution II</tradeName>
    <deviceName>Concentrated Cleaning Solution II</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050385</emdnCode>
    <emdnDescription>LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-W-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:15.601Z</lastUpdated>
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    <udiDi>06974735360309</udiDi>
    <basicUdiDi>697473536KUC11PH</basicUdiDi>
    <tradeName>KEYU Feces Analyzer Diluent Solution</tradeName>
    <deviceName>Feces Analyzer Diluent Solution</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02-B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:14.818Z</lastUpdated>
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    <udiDi>06974735360194</udiDi>
    <basicUdiDi>697473536KUC12PK</basicUdiDi>
    <tradeName>KEYU Sample Collection Container</tradeName>
    <deviceName>Sample Collection Container</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUP-D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:14.014Z</lastUpdated>
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    <basicUdiDi>697473536KUC10PF</basicUdiDi>
    <tradeName>KEYU Cleaning Solution</tradeName>
    <deviceName>Cleaning Solution</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050385</emdnCode>
    <emdnDescription>LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-SW02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:13.202Z</lastUpdated>
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    <udiDi>06974735360101</udiDi>
    <basicUdiDi>697473536KUC06PQ</basicUdiDi>
    <tradeName>KEYU Concentrated Cleaning Solution</tradeName>
    <deviceName>Concentrated Cleaning Solution</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202050385</emdnCode>
    <emdnDescription>LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-CCCS-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:09.213Z</lastUpdated>
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    <basicUdiDi>697473536KUC05PN</basicUdiDi>
    <tradeName>KEYU Sample Diluent</tradeName>
    <deviceName>Sample Diluent</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-R02-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:08.398Z</lastUpdated>
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    <basicUdiDi>697473536KUC03PJ</basicUdiDi>
    <tradeName>KEYU Maintenance Solution</tradeName>
    <deviceName>Maintenance Solution</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-M01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:07.596Z</lastUpdated>
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    <basicUdiDi>697473536KUC07PS</basicUdiDi>
    <tradeName>KEYU Sample Collection Cup</tradeName>
    <deviceName>Sample Collection Cup</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-CUP-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:20:06.797Z</lastUpdated>
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