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<eudamedExport entity="devices">
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    <udiDi>06936595752083</udiDi>
    <basicUdiDi>B-06936595752083</basicUdiDi>
    <tradeName>ISE 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>W0101070199</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK032Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:11.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752076</udiDi>
    <basicUdiDi>B-06936595752076</basicUdiDi>
    <tradeName>ISE 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>W0101070199</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ031Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:09.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752069</udiDi>
    <basicUdiDi>B-06936595752069</basicUdiDi>
    <tradeName>ISE Internal Standard</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>W0101070199</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISE030Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:07.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752052</udiDi>
    <basicUdiDi>B-06936595752052</basicUdiDi>
    <tradeName>ISE Standard</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>W0101070199</emdnCode>
    <emdnDescription>ELECTROLYTE ELECTRODES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JZ029Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:06.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751932</udiDi>
    <basicUdiDi>B-06936595751932</basicUdiDi>
    <tradeName>SARS-CoV-2 RT-PCR Test Kit</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>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR5101Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:05.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751925</udiDi>
    <basicUdiDi>B-06936595751925</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test</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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2500Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:03.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751918</udiDi>
    <basicUdiDi>B-06936595751918</basicUdiDi>
    <tradeName>Detect 5 Progressive Pregnancy Rapid Test</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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2500Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:01.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751901</udiDi>
    <basicUdiDi>B-06936595751901</basicUdiDi>
    <tradeName>High Sensitivity C-Reactive 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ021Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:00.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751895</udiDi>
    <basicUdiDi>B-06936595751895</basicUdiDi>
    <tradeName>Bicarbonate 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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ020Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:59.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751888</udiDi>
    <basicUdiDi>B-06936595751888</basicUdiDi>
    <tradeName>Bicarbonate 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>W01010302</emdnCode>
    <emdnDescription>BICARBONATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ019Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:58.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751871</udiDi>
    <basicUdiDi>B-06936595751871</basicUdiDi>
    <tradeName>Glycylproline Dipeptidyl Aminopeptidase Kit (Kinetic 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ018Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:55.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751864</udiDi>
    <basicUdiDi>B-06936595751864</basicUdiDi>
    <tradeName>Angiotensin Converting Enzyme Kit (Kinetic Method with FAPGG)</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>W01010109</emdnCode>
    <emdnDescription>ANGIOTENSIN CONVERTING ENZYME (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Angiotensin Converting Enzyme Kit (Kinetic Method with FAPGG)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:54.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751857</udiDi>
    <basicUdiDi>B-06936595751857</basicUdiDi>
    <tradeName>N-Acetyl-β-D-Glucosaminidase Kit (MPT 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>W01010126</emdnCode>
    <emdnDescription>N-ACETYL-B, D-GLUCOSAMINIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ016Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:53.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751840</udiDi>
    <basicUdiDi>B-06936595751840</basicUdiDi>
    <tradeName>5'-Nucleotidase Kit (Colorimetric Method with Peroxidase)</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>W01010101</emdnCode>
    <emdnDescription>5'-NUCLEOTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ015Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:52.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751833</udiDi>
    <basicUdiDi>B-06936595751833</basicUdiDi>
    <tradeName>Adenosine Deaminase Kit (Peroxidase 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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ014Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:49.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751826</udiDi>
    <basicUdiDi>B-06936595751826</basicUdiDi>
    <tradeName>α-L-Fucosidase Kit (Kinetic 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>W0102039018</emdnCode>
    <emdnDescription>ALPHA-FUCOSIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ013Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:48.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751819</udiDi>
    <basicUdiDi>B-06936595751819</basicUdiDi>
    <tradeName>Cholinesterase Kit (Butyrylthiocholine 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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ011Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:47.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751802</udiDi>
    <basicUdiDi>B-06936595751802</basicUdiDi>
    <tradeName>α-Hydroxybutyrate Dehydrogenase Kit (Kinetic 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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ010Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:46.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751796</udiDi>
    <basicUdiDi>B-06936595751796</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Kit (Kinetic 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ008Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:45.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751789</udiDi>
    <basicUdiDi>B-06936595751789</basicUdiDi>
    <tradeName>Creatine Kinase 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ006Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:42.745Z</lastUpdated>
  </row>
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