<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202239120</udiDi>
    <basicUdiDi>B-06942202239120</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</tradeName>
    <deviceName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014902</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:58.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239113</udiDi>
    <basicUdiDi>B-06942202239113</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014893</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:57.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239106</udiDi>
    <basicUdiDi>B-06942202239106</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016185</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:56.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239090</udiDi>
    <basicUdiDi>B-06942202239090</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>MYOGLOBIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012547</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:55.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239083</udiDi>
    <basicUdiDi>B-06942202239083</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014146</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:49.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239076</udiDi>
    <basicUdiDi>B-06942202239076</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014147</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:48.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239069</udiDi>
    <basicUdiDi>B-06942202239069</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014903</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:47.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239052</udiDi>
    <basicUdiDi>B-06942202239052</basicUdiDi>
    <tradeName>DIURI</tradeName>
    <deviceName>CARDIAC TROPONIN I REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009773</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:45.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239045</udiDi>
    <basicUdiDi>B-06942202239045</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC 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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012242</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:38.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239038</udiDi>
    <basicUdiDi>B-06942202239038</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC 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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003009</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:37.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239021</udiDi>
    <basicUdiDi>B-06942202239021</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL IRON-BINDING CAPACITY REAGENT KIT (FERENE 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>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012555</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:36.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239014</udiDi>
    <basicUdiDi>B-06942202239014</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL IRON-BINDING CAPACITY REAGENT KIT (FERENE 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>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002862</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:35.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239007</udiDi>
    <basicUdiDi>B-06942202239007</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ZINC REAGENT KIT（COLORIMETRIC 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>W01010233</emdnCode>
    <emdnDescription>ZINC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:29.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238994</udiDi>
    <basicUdiDi>B-06942202238994</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV 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>3012516</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:28.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238987</udiDi>
    <basicUdiDi>B-06942202238987</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV 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>3003107</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:25.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238970</udiDi>
    <basicUdiDi>B-06942202238970</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Copper Reagent Kit (PAESA Chromogenic Agent 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>W01010206</emdnCode>
    <emdnDescription>COPPER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012960</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:24.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238963</udiDi>
    <basicUdiDi>B-06942202238963</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Fe REAGENT KIT (FERENE 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>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012497</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:18.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238956</udiDi>
    <basicUdiDi>B-06942202238956</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Fe REAGENT KIT (FERENE 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>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002854</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:16.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238949</udiDi>
    <basicUdiDi>B-06942202238949</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Sodium Reagent Kit(Galactosidase 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>3016061</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:16.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238932</udiDi>
    <basicUdiDi>B-06942202238932</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Sodium Reagent Kit(Galactosidase 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>3015887</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:15:14.866Z</lastUpdated>
  </row>
</eudamedExport>