<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936595751772</udiDi>
    <basicUdiDi>B-06936595751772</basicUdiDi>
    <tradeName>γ-Glutamyltransferase Kit (GCANA 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>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ005Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:41.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751765</udiDi>
    <basicUdiDi>B-06936595751765</basicUdiDi>
    <tradeName>Coronavirus Disease 2019 Real Time PCR 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>2026-06-24T15:57:40.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751758</udiDi>
    <basicUdiDi>B-06936595751758</basicUdiDi>
    <tradeName>COVID-19 Ag Rapid Test Cassette</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>CG2302TY1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:39.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751741</udiDi>
    <basicUdiDi>B-06936595751741</basicUdiDi>
    <tradeName>Lipid Dry Chemistry 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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK2203Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:36.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751734</udiDi>
    <basicUdiDi>B-06936595751734</basicUdiDi>
    <tradeName>Insulin-Like Growth Factor Binding Protein 3 Kit(CLIA)</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>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1904Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:35.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751727</udiDi>
    <basicUdiDi>B-06936595751727</basicUdiDi>
    <tradeName>Gastrin-17 Kit(CLIA)</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>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1902Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:34.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751710</udiDi>
    <basicUdiDi>B-06936595751710</basicUdiDi>
    <tradeName>Insulin-Like Growth Factor-I Kit(CLIA)</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>W0102060403</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1901Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:33.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751703</udiDi>
    <basicUdiDi>B-06936595751703</basicUdiDi>
    <tradeName>Treponema Pallidum Antibodies Kit(CLIA)</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>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1506Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:31.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751697</udiDi>
    <basicUdiDi>B-06936595751697</basicUdiDi>
    <tradeName>Interleukin-6 Kit(CLIA)</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>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1471Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:29.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751680</udiDi>
    <basicUdiDi>B-06936595751680</basicUdiDi>
    <tradeName>Procalcitonin Kit (CLIA)</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>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1470Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:28.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751673</udiDi>
    <basicUdiDi>B-06936595751673</basicUdiDi>
    <tradeName>Total Procollagen I N-Terminal Propeptide Kit (CLIA)</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>W0102060317</emdnCode>
    <emdnDescription>PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1454Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:27.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751666</udiDi>
    <basicUdiDi>B-06936595751666</basicUdiDi>
    <tradeName>Vitamin B12 Kit (CLIA)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1453Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:25.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751659</udiDi>
    <basicUdiDi>B-06936595751659</basicUdiDi>
    <tradeName>Folate  Kit (CLIA)</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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1452Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:23.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751642</udiDi>
    <basicUdiDi>B-06936595751642</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin D Total Kit (CLIA)</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1451Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:22.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751635</udiDi>
    <basicUdiDi>B-06936595751635</basicUdiDi>
    <tradeName>Intact Parathyroid Hormone Kit (CLIA)</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>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1450Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:21.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751628</udiDi>
    <basicUdiDi>B-06936595751628</basicUdiDi>
    <tradeName>Angiotensin II Kit  (CLIA)</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1426Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:19.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751611</udiDi>
    <basicUdiDi>B-06936595751611</basicUdiDi>
    <tradeName>Angiotensin I Kit  (CLIA)</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1425Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:18.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751604</udiDi>
    <basicUdiDi>B-06936595751604</basicUdiDi>
    <tradeName>Cortisol Kit (CLIA)</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1424Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:16.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751598</udiDi>
    <basicUdiDi>B-06936595751598</basicUdiDi>
    <tradeName>Renin Kit (CLIA)</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>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1423Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:15.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751581</udiDi>
    <basicUdiDi>B-06936595751581</basicUdiDi>
    <tradeName>Growth Hormone Kit (CLIA)</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>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1422Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:13.907Z</lastUpdated>
  </row>
</eudamedExport>