<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>2026-08-03T14:16:05.593Z</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>232014702002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:49.413Z</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>2026-08-03T14:15:48.712Z</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>2026-08-03T14:15:47.006Z</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>232013002006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:46.212Z</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>2026-08-03T14:15:41.407Z</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>2026-08-03T14:15:40.608Z</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>232015502006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:39.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246982</udiDi>
    <basicUdiDi>B-06942202246982</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>3016165</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:39.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246975</udiDi>
    <basicUdiDi>B-06942202246975</basicUdiDi>
    <tradeName>α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）</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>232013202007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:34.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246968</udiDi>
    <basicUdiDi>B-06942202246968</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015064</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:33.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246951</udiDi>
    <basicUdiDi>B-06942202246951</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015078</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:32.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246944</udiDi>
    <basicUdiDi>B-06942202246944</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015056</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:31.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246937</udiDi>
    <basicUdiDi>B-06942202246937</basicUdiDi>
    <tradeName>ZINC REAGENT KIT（COLORIMETRIC METHOD）</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>232014302002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:26.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246920</udiDi>
    <basicUdiDi>B-06942202246920</basicUdiDi>
    <tradeName>Copper Reagent Kit (PAESA Chromogenic Agent Assay)</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>3011909</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:25.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246913</udiDi>
    <basicUdiDi>B-06942202246913</basicUdiDi>
    <tradeName>Copper Reagent Kit (PAESA Chromogenic Agent Assay)</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>3011769</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:24.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246906</udiDi>
    <basicUdiDi>B-06942202246906</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</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>3015967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:23.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246890</udiDi>
    <basicUdiDi>B-06942202246890</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</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>3015852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:19.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246883</udiDi>
    <basicUdiDi>B-06942202246883</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</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>3015966</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:18.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246876</udiDi>
    <basicUdiDi>B-06942202246876</basicUdiDi>
    <tradeName>CHLORIDE REAGENT KIT (THIOCYANATE METHOD)</tradeName>
    <deviceName>CHLORIDE REAGENT KIT (THIOCYANATE 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>232013602003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:18.191Z</lastUpdated>
  </row>
</eudamedExport>