<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973602150418</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-A1600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602150517</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-H2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602150616</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-H0mini</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602150623</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-H0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151415</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-M2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151422</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC-M2NT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602151439</udiDi>
    <basicUdiDi>697360215FICNY</basicUdiDi>
    <tradeName>Dry Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Helmen Precision Insturments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002230</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIC- NTIMM3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861681722</udiDi>
    <basicUdiDi>6973861681647FP</basicUdiDi>
    <tradeName>Anbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861681739</udiDi>
    <basicUdiDi>6973861681647FP</basicUdiDi>
    <tradeName>Anbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-100S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861681746</udiDi>
    <basicUdiDi>6973861681647FP</basicUdiDi>
    <tradeName>Anbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861682569</udiDi>
    <basicUdiDi>6973861682552FJ</basicUdiDi>
    <tradeName>Anbio Biotechnology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio Biotechnology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000042849</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-100S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861682576</udiDi>
    <basicUdiDi>6973861682552FJ</basicUdiDi>
    <tradeName>Anbio Biotechnology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio Biotechnology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000042849</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-100C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973861682590</udiDi>
    <basicUdiDi>6973861682552FJ</basicUdiDi>
    <tradeName>Anbio Biotechnology</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Anbio Biotechnology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000042849</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:13:42.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973873149036</udiDi>
    <basicUdiDi>697387314HBCTQ</basicUdiDi>
    <tradeName>Automatic Hybrid Capture System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>Humiss Beratung GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023447</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>HB-304C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:12:56.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973873149043</udiDi>
    <basicUdiDi>697387314HBCTQ</basicUdiDi>
    <tradeName>Automatic Hybrid Capture System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>Humiss Beratung GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023447</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>HB-314C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:12:56.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974201151875</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCLia minus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:09:14.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974201151882</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCLia plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:09:14.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974201151899</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCLia auto</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:09:14.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974201151981</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIA 600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:09:14.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974201151998</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIA 1200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:09:14.076Z</lastUpdated>
  </row>
</eudamedExport>