<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202235702</udiDi>
    <basicUdiDi>B-06942202235702</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Apolipoprotein E Reagent Kit (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>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011811</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:40.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235696</udiDi>
    <basicUdiDi>B-06942202235696</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Free Fatty Acid Reagent Kit (ACS-ACOD 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011565</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:39.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235689</udiDi>
    <basicUdiDi>B-06942202235689</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Phospholipid Reagent Kit (Choline Oxide 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>W01010224</emdnCode>
    <emdnDescription>PHOSPHOLIPIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:38.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235672</udiDi>
    <basicUdiDi>B-06942202235672</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(HEXOKINASE METHOD)</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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000580</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:37.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235665</udiDi>
    <basicUdiDi>B-06942202235665</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay )</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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011636</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:31.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235610</udiDi>
    <basicUdiDi>B-06942202235610</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025841</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:30.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235603</udiDi>
    <basicUdiDi>B-06942202235603</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025868</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:28.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235597</udiDi>
    <basicUdiDi>B-06942202235597</basicUdiDi>
    <tradeName>ISE Internal Standard Solution</tradeName>
    <deviceName>ISE Internal Standard Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025859</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:27.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235573</udiDi>
    <basicUdiDi>B-06942202235573</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025856</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:21.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235054</udiDi>
    <basicUdiDi>B-06942202235054</basicUdiDi>
    <tradeName>Clinical Chemical Calibration Serum</tradeName>
    <deviceName>Clinical Chemical Calibration 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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025740</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:20.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235047</udiDi>
    <basicUdiDi>B-06942202235047</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-3000Plus</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:19.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235023</udiDi>
    <basicUdiDi>B-06942202235023</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025731</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:18.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235016</udiDi>
    <basicUdiDi>B-06942202235016</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025723</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:10.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202235009</udiDi>
    <basicUdiDi>B-06942202235009</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025734</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:09.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234996</udiDi>
    <basicUdiDi>B-06942202234996</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025722</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:08.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234989</udiDi>
    <basicUdiDi>B-06942202234989</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025724</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:07.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234972</udiDi>
    <basicUdiDi>B-06942202234972</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025736</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:01.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234965</udiDi>
    <basicUdiDi>B-06942202234965</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025728</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:08:00.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234958</udiDi>
    <basicUdiDi>B-06942202234958</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025732</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:59.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202234941</udiDi>
    <basicUdiDi>B-06942202234941</basicUdiDi>
    <tradeName>Clinical Chemistry Calibrator</tradeName>
    <deviceName>Clinical Chemistry Calibrator</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>W0101050399</emdnCode>
    <emdnDescription>CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025735</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:07:56.511Z</lastUpdated>
  </row>
</eudamedExport>