<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974312710565</udiDi>
    <basicUdiDi>697431271001H2</basicUdiDi>
    <tradeName>Automatic nucleic acid extractor</tradeName>
    <deviceName>Automatic nucleic acid extractor</deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMART-0596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:50:56.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710398</udiDi>
    <basicUdiDi>697431271003H6</basicUdiDi>
    <tradeName>Sample Processing System</tradeName>
    <deviceName>Sample Processing System</deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Magic-4000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:50:52.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710367</udiDi>
    <basicUdiDi>697431271005HA</basicUdiDi>
    <tradeName>Sample Processing System</tradeName>
    <deviceName>Sample Processing System</deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Magic-2000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:50:51.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710008</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName>Fully Automatic ELISA Analyzer</deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:50:50.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710015</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710022</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2000Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710039</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-2000Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710046</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710053</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-4000Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710060</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-4000Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710077</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-4800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710084</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-4800Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710091</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME4800Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710107</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710114</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8000Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710121</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8000Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710138</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710145</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8400Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710152</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8400Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974312710169</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-8800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:05:53.150Z</lastUpdated>
  </row>
</eudamedExport>