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<eudamedExport entity="devices">
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    <udiDi>06937339203489</udiDi>
    <basicUdiDi>B-06937339203489</basicUdiDi>
    <tradeName>VivaChek Fad Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGC02-031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:16.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339203472</udiDi>
    <basicUdiDi>B-06937339203472</basicUdiDi>
    <tradeName>VivaChek Eco Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGC01-021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:15.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339202420</udiDi>
    <basicUdiDi>B-06937339202420</basicUdiDi>
    <tradeName>Paski testowe do pomiaru stężenia glukozy we krwi VivaChek Fad</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-037</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:08.460Z</lastUpdated>
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  <row>
    <udiDi>06937339200273</udiDi>
    <basicUdiDi>B-06937339200273</basicUdiDi>
    <tradeName>Bandelette de glycémie Vivachek Ino</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-01A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:00.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339200266</udiDi>
    <basicUdiDi>B-06937339200266</basicUdiDi>
    <tradeName>Solution de contrôle pour la glycémie Vivachek Ino</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGC01-011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:58.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339200259</udiDi>
    <basicUdiDi>B-06937339200259</basicUdiDi>
    <tradeName>Bandelette de glycémie Vivachek Ino</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-011</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:56.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752427</udiDi>
    <basicUdiDi>B-06936595752427</basicUdiDi>
    <tradeName>Twelve biochemical</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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2213Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:59:00.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752410</udiDi>
    <basicUdiDi>B-06936595752410</basicUdiDi>
    <tradeName>Eleven biochemical</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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2212Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:59.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752403</udiDi>
    <basicUdiDi>B-06936595752403</basicUdiDi>
    <tradeName>Comprehensive biochemistry of liver and kidney glycolipid</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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2207Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:58.407Z</lastUpdated>
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  <row>
    <udiDi>06936595752397</udiDi>
    <basicUdiDi>B-06936595752397</basicUdiDi>
    <tradeName>Seven Glycosidone Lipids Biochemistry</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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2208Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:55.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752380</udiDi>
    <basicUdiDi>B-06936595752380</basicUdiDi>
    <tradeName>Six Cardiovascular and Cerebrovascular Syntheses</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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2209Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:54.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752373</udiDi>
    <basicUdiDi>B-06936595752373</basicUdiDi>
    <tradeName>Growth Stimulation Expressed Gene2 Protein FIA 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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2013Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:53.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752366</udiDi>
    <basicUdiDi>B-06936595752366</basicUdiDi>
    <tradeName>Hemoglobin A1c FIA 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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2012Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:52.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752359</udiDi>
    <basicUdiDi>B-06936595752359</basicUdiDi>
    <tradeName>Troponin I FIA 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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2011Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:51.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752342</udiDi>
    <basicUdiDi>B-06936595752342</basicUdiDi>
    <tradeName>D-Dimer FIA 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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2010Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:48.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752335</udiDi>
    <basicUdiDi>B-06936595752335</basicUdiDi>
    <tradeName>Anti Mullerian Horrmone FIA 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>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YG2009Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:47.587Z</lastUpdated>
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    <udiDi>06936595752328</udiDi>
    <basicUdiDi>B-06936595752328</basicUdiDi>
    <tradeName>Alanine Aminotransferase &amp; Hemoglobin Dry Chemistry 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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2210Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:46.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752311</udiDi>
    <basicUdiDi>B-06936595752311</basicUdiDi>
    <tradeName>Alanine Aminotransferase &amp; Aspartate Aminotransferase Dry Chemistry 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>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2211Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:45.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752298</udiDi>
    <basicUdiDi>B-06936595752298</basicUdiDi>
    <tradeName>LH Ovulation 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>CG2501Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:41.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595752236</udiDi>
    <basicUdiDi>B-06936595752236</basicUdiDi>
    <tradeName>Hemoglobin A1c Dry Chemistry 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>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2204Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:33.216Z</lastUpdated>
  </row>
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