<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VID144EZ</udiDi>
    <basicUdiDi>B-VID144EZ</basicUdiDi>
    <tradeName>Beta Amyloid 40 Test Kit (FIA)</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>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID144-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:57.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BV4191423U</udiDi>
    <basicUdiDi>B-BV4191423U</basicUdiDi>
    <tradeName>D-BV4191423U</tradeName>
    <deviceName>HISCL β-Amyloid 1-40 Assay kit</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV419142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:04.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BL170013UX</udiDi>
    <basicUdiDi>B-BL170013UX</basicUdiDi>
    <tradeName>D-BL170013UX</tradeName>
    <deviceName>HISCL β-Amyloid 1-40 Calibrator</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL170013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:27:02.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323352</udiDi>
    <basicUdiDi>B-06975531323352</basicUdiDi>
    <tradeName>06975531323352</tradeName>
    <deviceName>Human Beta-amyloid (ABeta) test kit (Lateral flow immunochromatography assay)</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:21.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719605637</udiDi>
    <basicUdiDi>B-06972719605637</basicUdiDi>
    <tradeName>06972719605637</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:50:22.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719605620</udiDi>
    <basicUdiDi>B-06972719605620</basicUdiDi>
    <tradeName>06972719605620</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:50:21.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719603497</udiDi>
    <basicUdiDi>B-06972719603497</basicUdiDi>
    <tradeName>06972719603497</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:43:02.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719603480</udiDi>
    <basicUdiDi>B-06972719603480</basicUdiDi>
    <tradeName>06972719603480</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:43:00.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719603473</udiDi>
    <basicUdiDi>B-06972719603473</basicUdiDi>
    <tradeName>06972719603473</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:58.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972719603466</udiDi>
    <basicUdiDi>B-06972719603466</basicUdiDi>
    <tradeName>06972719603466</tradeName>
    <deviceName>Amyloid β Protein 1-40 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019013</emdnCode>
    <emdnDescription>BETA-AMYLOID (1-40)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:42:57.602Z</lastUpdated>
  </row>
</eudamedExport>