<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202239328</udiDi>
    <basicUdiDi>B-06942202239328</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>3012989</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:47.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239311</udiDi>
    <basicUdiDi>B-06942202239311</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012551</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:45.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239304</udiDi>
    <basicUdiDi>B-06942202239304</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000727</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:44.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239298</udiDi>
    <basicUdiDi>B-06942202239298</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（OXIDASE 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012491</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:43.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239281</udiDi>
    <basicUdiDi>B-06942202239281</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（OXIDASE 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:37.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239274</udiDi>
    <basicUdiDi>B-06942202239274</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012552</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:36.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239267</udiDi>
    <basicUdiDi>B-06942202239267</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000742</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:34.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239250</udiDi>
    <basicUdiDi>B-06942202239250</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CHOLESTEROL REAGENT KIT（ENZYME 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>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012548</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:33.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239243</udiDi>
    <basicUdiDi>B-06942202239243</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CHOLESTEROL REAGENT KIT（ENZYME 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>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012232</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:27.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239236</udiDi>
    <basicUdiDi>B-06942202239236</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CHOLESTEROL REAGENT KIT（ENZYME 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>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000691</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:26.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239229</udiDi>
    <basicUdiDi>B-06942202239229</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014895</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:25.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239212</udiDi>
    <basicUdiDi>B-06942202239212</basicUdiDi>
    <tradeName>Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay)</tradeName>
    <deviceName>Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition 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>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012875</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:24.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239205</udiDi>
    <basicUdiDi>B-06942202239205</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012532</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:18.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239199</udiDi>
    <basicUdiDi>B-06942202239199</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:17.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239182</udiDi>
    <basicUdiDi>B-06942202239182</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002192</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:16.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239175</udiDi>
    <basicUdiDi>B-06942202239175</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ischemic Modified Albumin Reagent Kit (ACB 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013028</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:14.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239168</udiDi>
    <basicUdiDi>B-06942202239168</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ischemic Modified Albumin Reagent Kit (ACB 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011744</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:08.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239151</udiDi>
    <basicUdiDi>B-06942202239151</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ischemic Modified Albumin Reagent Kit (ACB 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011606</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:07.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239144</udiDi>
    <basicUdiDi>B-06942202239144</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012539</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:06.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239137</udiDi>
    <basicUdiDi>B-06942202239137</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000758</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:16:04.981Z</lastUpdated>
  </row>
</eudamedExport>