<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202256653</udiDi>
    <basicUdiDi>B-06942202256653</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSM-8000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:17:14.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202256646</udiDi>
    <basicUdiDi>B-06942202256646</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSM-8000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:17:10.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202256622</udiDi>
    <basicUdiDi>B-06942202256622</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSM-8000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:17:09.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202256615</udiDi>
    <basicUdiDi>B-06942202256615</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012562</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:17:08.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202256639</udiDi>
    <basicUdiDi>B-06942202256639</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSM-8000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:17:07.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577115</udiDi>
    <basicUdiDi>B-06925794577115</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CSM-9000 Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 biochemistry module + 1 immunoassay module + 1 sample unit +1ISE module+ 1 detergent proportioning module etc</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:32.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577108</udiDi>
    <basicUdiDi>B-06925794577108</basicUdiDi>
    <tradeName>Integrated System</tradeName>
    <deviceName>Integrated System</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030103</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HIGH ROUTINE (Throughput &gt; 2000 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSM-9000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:31.827Z</lastUpdated>
  </row>
</eudamedExport>