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<eudamedExport entity="devices">
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    <udiDi>06936595750577</udiDi>
    <basicUdiDi>B-06936595750577</basicUdiDi>
    <tradeName>Ammonia Kit (Enzymatic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010301</emdnCode>
    <emdnDescription>AMMONIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ436Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:46.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750560</udiDi>
    <basicUdiDi>B-06936595750560</basicUdiDi>
    <tradeName>Ethanol Kit (Enzymatic Kinetic UV Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ435Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:45.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750553</udiDi>
    <basicUdiDi>B-06936595750553</basicUdiDi>
    <tradeName>Lactate Kit (Enzymatic UV Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010218</emdnCode>
    <emdnDescription>LACTATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ434Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:43.808Z</lastUpdated>
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  <row>
    <udiDi>06936595750546</udiDi>
    <basicUdiDi>B-06936595750546</basicUdiDi>
    <tradeName>Chloride Kit (Mercuricthiocyanate Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010304</emdnCode>
    <emdnDescription>CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ433Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:42.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750539</udiDi>
    <basicUdiDi>B-06936595750539</basicUdiDi>
    <tradeName>Sodium Kit (Enzymatic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010309</emdnCode>
    <emdnDescription>SODIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ432Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:40.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750522</udiDi>
    <basicUdiDi>B-06936595750522</basicUdiDi>
    <tradeName>Potassium Kit (Enzymatic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010308</emdnCode>
    <emdnDescription>POTASSIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ431Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:39.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750515</udiDi>
    <basicUdiDi>B-06936595750515</basicUdiDi>
    <tradeName>Ischemia-Modified Albumin Kit (Albumin Cobalt Binding Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ430Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:37.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750508</udiDi>
    <basicUdiDi>B-06936595750508</basicUdiDi>
    <tradeName>Glycated Albumin Kit (Enzymatic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060199</emdnCode>
    <emdnDescription>DIABETES ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ429Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:36.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750492</udiDi>
    <basicUdiDi>B-06936595750492</basicUdiDi>
    <tradeName>Apolipoprotein E Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010404</emdnCode>
    <emdnDescription>APOLIPOPROTEIN E SUB-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ428Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:35.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750485</udiDi>
    <basicUdiDi>B-06936595750485</basicUdiDi>
    <tradeName>α1-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019004</emdnCode>
    <emdnDescription>A1-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ426Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:32.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750478</udiDi>
    <basicUdiDi>B-06936595750478</basicUdiDi>
    <tradeName>Retinol Binding Protein Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010306</emdnCode>
    <emdnDescription>RETINOL BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ425Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:31.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750461</udiDi>
    <basicUdiDi>B-06936595750461</basicUdiDi>
    <tradeName>D-Dimer Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ424Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:30.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750454</udiDi>
    <basicUdiDi>B-06936595750454</basicUdiDi>
    <tradeName>D-Dimer Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK424Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:29.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750447</udiDi>
    <basicUdiDi>B-06936595750447</basicUdiDi>
    <tradeName>D-Dimer Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ424Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:26.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750430</udiDi>
    <basicUdiDi>B-06936595750430</basicUdiDi>
    <tradeName>Cardiac Troponin I Kit(Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ423Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:25.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750423</udiDi>
    <basicUdiDi>B-06936595750423</basicUdiDi>
    <tradeName>Cardiac Troponin I Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152004</emdnCode>
    <emdnDescription>CARDIAC MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK423Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:24.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750416</udiDi>
    <basicUdiDi>B-06936595750416</basicUdiDi>
    <tradeName>Cardiac Troponin I Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152204</emdnCode>
    <emdnDescription>CARDIAC MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ423Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:23.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750409</udiDi>
    <basicUdiDi>B-06936595750409</basicUdiDi>
    <tradeName>Homocysteine Kit (Enzyme Cycling Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021307</emdnCode>
    <emdnDescription>HOMOCYSTEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ422Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:22.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750393</udiDi>
    <basicUdiDi>B-06936595750393</basicUdiDi>
    <tradeName>Myoglobin Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ421Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:19.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750386</udiDi>
    <basicUdiDi>B-06936595750386</basicUdiDi>
    <tradeName>Glycated Hemoglobin A1c Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152208</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR INDIVIDUAL AND SPECIFIC HORMONES /PROTEINS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ420Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:18.585Z</lastUpdated>
  </row>
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