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<eudamedExport entity="devices">
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    <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>2026-06-26T12:24:58.155Z</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>2026-06-26T12:24:57.067Z</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>2026-06-26T12:24:54.542Z</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>2026-06-26T12:24:53.339Z</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>2026-06-26T12:24:47.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202254826</udiDi>
    <basicUdiDi>B-06942202254826</basicUdiDi>
    <tradeName>Urinalysis Hybrid</tradeName>
    <deviceName>Urinalysis Hybrid</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:46.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247323</udiDi>
    <basicUdiDi>B-06942202247323</basicUdiDi>
    <tradeName>ISE Urine Control</tradeName>
    <deviceName>ISE Urine Control</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>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011990</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:44.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247316</udiDi>
    <basicUdiDi>B-06942202247316</basicUdiDi>
    <tradeName>ISE Urine Control</tradeName>
    <deviceName>ISE Urine Control</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>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012119</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:43.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247309</udiDi>
    <basicUdiDi>B-06942202247309</basicUdiDi>
    <tradeName>ISE Urine Control</tradeName>
    <deviceName>ISE Urine Control</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>W0101050199</emdnCode>
    <emdnDescription>MULTICOMPONENT CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012147</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:37.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247293</udiDi>
    <basicUdiDi>B-06942202247293</basicUdiDi>
    <tradeName>ISE Urine Calibrator</tradeName>
    <deviceName>ISE Urine Calibrator</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011950</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:35.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247286</udiDi>
    <basicUdiDi>B-06942202247286</basicUdiDi>
    <tradeName>ISE Urine Calibrator</tradeName>
    <deviceName>ISE Urine Calibrator</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012079</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:34.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247279</udiDi>
    <basicUdiDi>B-06942202247279</basicUdiDi>
    <tradeName>ISE Urine Calibrator</tradeName>
    <deviceName>ISE Urine Calibrator</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011989</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:33.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247262</udiDi>
    <basicUdiDi>B-06942202247262</basicUdiDi>
    <tradeName>ISE Urine Calibrator</tradeName>
    <deviceName>ISE Urine Calibrator</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012148</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:27.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247255</udiDi>
    <basicUdiDi>B-06942202247255</basicUdiDi>
    <tradeName>Lipid Control Serum</tradeName>
    <deviceName>Lipid Control Serum</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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003171</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:25.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247248</udiDi>
    <basicUdiDi>B-06942202247248</basicUdiDi>
    <tradeName>Lipid Control Serum</tradeName>
    <deviceName>Lipid Control Serum</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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003169</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:24.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247231</udiDi>
    <basicUdiDi>B-06942202247231</basicUdiDi>
    <tradeName>Lipid Control Serum</tradeName>
    <deviceName>Lipid Control Serum</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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003165</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:22.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247224</udiDi>
    <basicUdiDi>B-06942202247224</basicUdiDi>
    <tradeName>Lipid Control Serum</tradeName>
    <deviceName>Lipid Control Serum</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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003163</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:16.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247217</udiDi>
    <basicUdiDi>B-06942202247217</basicUdiDi>
    <tradeName>Specific Protein Control Serum</tradeName>
    <deviceName>Specific Protein Control Serum</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003157</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:14.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247200</udiDi>
    <basicUdiDi>B-06942202247200</basicUdiDi>
    <tradeName>Specific Protein Control Serum</tradeName>
    <deviceName>Specific Protein Control Serum</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003151</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:13.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247194</udiDi>
    <basicUdiDi>B-06942202247194</basicUdiDi>
    <tradeName>Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)</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>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011827</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:12.551Z</lastUpdated>
  </row>
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