<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202237911</udiDi>
    <basicUdiDi>B-06942202237911</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012493</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:53.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237904</udiDi>
    <basicUdiDi>B-06942202237904</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (Diazo Salt 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016490</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:49.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237898</udiDi>
    <basicUdiDi>B-06942202237898</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (Diazo Salt 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:49.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237881</udiDi>
    <basicUdiDi>B-06942202237881</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012514</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:48.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237874</udiDi>
    <basicUdiDi>B-06942202237874</basicUdiDi>
    <tradeName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION METHOD）</tradeName>
    <deviceName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232010902103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:47.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237867</udiDi>
    <basicUdiDi>B-06942202237867</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>DIRECT BILIRUBIN REAGENT KIT(DIAZO SALT 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012513</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:43.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237850</udiDi>
    <basicUdiDi>B-06942202237850</basicUdiDi>
    <tradeName>ISOCITRATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>ISOCITRATE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232011402011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:42.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237843</udiDi>
    <basicUdiDi>B-06942202237843</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ISOCITRATE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012494</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:41.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237836</udiDi>
    <basicUdiDi>B-06942202237836</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ADENOSINE DEAMINASE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014884</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:41.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237805</udiDi>
    <basicUdiDi>B-06942202237805</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Mitochondrial Aspartate Aminotransferase 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:35.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237799</udiDi>
    <basicUdiDi>B-06942202237799</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ASPARTATE AMINOTRANSFERASE 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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012529</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:34.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237782</udiDi>
    <basicUdiDi>B-06942202237782</basicUdiDi>
    <tradeName>ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>ASPARTATE AMINOTRANSFERASE 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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232010202012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:30.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237768</udiDi>
    <basicUdiDi>B-06942202237768</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS）</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>W01010122</emdnCode>
    <emdnDescription>LEUCINE AMINOPEPTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012542</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:29.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237751</udiDi>
    <basicUdiDi>B-06942202237751</basicUdiDi>
    <tradeName>LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS）</tradeName>
    <deviceName>LEUCINE AMINOPEPTIDASE REAGENT KIT（SUBSTRATE HYDROLYSIS）</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>W01010122</emdnCode>
    <emdnDescription>LEUCINE AMINOPEPTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232011502011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:28.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237744</udiDi>
    <basicUdiDi>B-06942202237744</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>ALKALINE PHOSPHATASE 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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012537</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:24.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237737</udiDi>
    <basicUdiDi>B-06942202237737</basicUdiDi>
    <tradeName>ALKALINE PHOSPHATASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>ALKALINE PHOSPHATASE 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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232010402012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:23.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237720</udiDi>
    <basicUdiDi>B-06942202237720</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUTAMATE DEHYDROGENASE REAGENT KIT（THE IMPROVED 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>W01010117</emdnCode>
    <emdnDescription>GLUTAMATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012549</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:22.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237713</udiDi>
    <basicUdiDi>B-06942202237713</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>3012816</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:21.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237706</udiDi>
    <basicUdiDi>B-06942202237706</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:17.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237690</udiDi>
    <basicUdiDi>B-06942202237690</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CHOLINSTERASE REAGENT KIT（BUTYRYL THIOCHOLINE 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>W01010111</emdnCode>
    <emdnDescription>CHOLINESTERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012521</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:17.062Z</lastUpdated>
  </row>
</eudamedExport>