<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202247187</udiDi>
    <basicUdiDi>B-06942202247187</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>3011560</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:05.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247170</udiDi>
    <basicUdiDi>B-06942202247170</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002328</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:04.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247163</udiDi>
    <basicUdiDi>B-06942202247163</basicUdiDi>
    <tradeName>Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)</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>3011549</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:03.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247156</udiDi>
    <basicUdiDi>B-06942202247156</basicUdiDi>
    <tradeName>Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein C2 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>3011912</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:24:01.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247149</udiDi>
    <basicUdiDi>B-06942202247149</basicUdiDi>
    <tradeName>Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein C2 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>3011774</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:55.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247132</udiDi>
    <basicUdiDi>B-06942202247132</basicUdiDi>
    <tradeName>APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN B REAGENT KIT（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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004634</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:54.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247125</udiDi>
    <basicUdiDi>B-06942202247125</basicUdiDi>
    <tradeName>APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN B REAGENT KIT（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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001729</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:53.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247118</udiDi>
    <basicUdiDi>B-06942202247118</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011777</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:52.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247101</udiDi>
    <basicUdiDi>B-06942202247101</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011735</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:45.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247095</udiDi>
    <basicUdiDi>B-06942202247095</basicUdiDi>
    <tradeName>APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN A1 REAGENT KIT（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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002327</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:43.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247088</udiDi>
    <basicUdiDi>B-06942202247088</basicUdiDi>
    <tradeName>Free Fatty Acid Reagent Kit (ACS-ACOD Assay)</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>3011903</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:42.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247071</udiDi>
    <basicUdiDi>B-06942202247071</basicUdiDi>
    <tradeName>Phospholipid Reagent Kit (Choline Oxide Assay)</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>3011603</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:41.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247064</udiDi>
    <basicUdiDi>B-06942202247064</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</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>3005503</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:35.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247057</udiDi>
    <basicUdiDi>B-06942202247057</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</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>3001697</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:33.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247040</udiDi>
    <basicUdiDi>B-06942202247040</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>3011816</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:31.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247033</udiDi>
    <basicUdiDi>B-06942202247033</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>3011484</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:30.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247026</udiDi>
    <basicUdiDi>B-06942202247026</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>3000772</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:24.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247019</udiDi>
    <basicUdiDi>B-06942202247019</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>3004693</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:23.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202247002</udiDi>
    <basicUdiDi>B-06942202247002</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>3004690</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:20.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246999</udiDi>
    <basicUdiDi>B-06942202246999</basicUdiDi>
    <tradeName>MYOGLOBIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</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>3004448</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:19.678Z</lastUpdated>
  </row>
</eudamedExport>