<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202258817</udiDi>
    <basicUdiDi>B-06942202258817</basicUdiDi>
    <tradeName>Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase Assay)</tradeName>
    <deviceName>Monoamine Oxidase Reagent Kit (Glutamate Dehydrogenase 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>3012951</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:23.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258800</udiDi>
    <basicUdiDi>B-06942202258800</basicUdiDi>
    <tradeName>ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD）</tradeName>
    <deviceName>ALANINE AMINOTRANSFERASE LIQUID 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>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016536</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:22.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258794</udiDi>
    <basicUdiDi>B-06942202258794</basicUdiDi>
    <tradeName>ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD）</tradeName>
    <deviceName>ALANINE AMINOTRANSFERASE LIQUID 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>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016544</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:21.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258787</udiDi>
    <basicUdiDi>B-06942202258787</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000546</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:19.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258770</udiDi>
    <basicUdiDi>B-06942202258770</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000545</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:14.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258763</udiDi>
    <basicUdiDi>B-06942202258763</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016547</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:12.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258756</udiDi>
    <basicUdiDi>B-06942202258756</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021171</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:11.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258749</udiDi>
    <basicUdiDi>B-06942202258749</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016518</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:10.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258732</udiDi>
    <basicUdiDi>B-06942202258732</basicUdiDi>
    <tradeName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>γ-GLUTAMYL TRANSFERASE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000442</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:04.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258725</udiDi>
    <basicUdiDi>B-06942202258725</basicUdiDi>
    <tradeName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>γ-GLUTAMYL TRANSFERASE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016541</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:03.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258718</udiDi>
    <basicUdiDi>B-06942202258718</basicUdiDi>
    <tradeName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>γ-GLUTAMYL TRANSFERASE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016520</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:01.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258701</udiDi>
    <basicUdiDi>B-06942202258701</basicUdiDi>
    <tradeName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>γ-GLUTAMYL TRANSFERASE 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000444</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:27:00.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258695</udiDi>
    <basicUdiDi>B-06942202258695</basicUdiDi>
    <tradeName>α-L-Fucosidase Reagent Kit (CNPF Substrate Method)</tradeName>
    <deviceName>α-L-Fucosidase Reagent Kit (CNPF 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>3021149</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:54.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258688</udiDi>
    <basicUdiDi>B-06942202258688</basicUdiDi>
    <tradeName>5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>5’-NUCLEOTIDASE 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>W01010101</emdnCode>
    <emdnDescription>5'-NUCLEOTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:53.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258671</udiDi>
    <basicUdiDi>B-06942202258671</basicUdiDi>
    <tradeName>5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>5’-NUCLEOTIDASE 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>W01010101</emdnCode>
    <emdnDescription>5'-NUCLEOTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021198</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:52.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258664</udiDi>
    <basicUdiDi>B-06942202258664</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-1600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:51.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258657</udiDi>
    <basicUdiDi>B-06942202258657</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010103</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Random access without ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-1600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:45.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258640</udiDi>
    <basicUdiDi>B-06942202258640</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010104</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-2000i</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:43.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258633</udiDi>
    <basicUdiDi>B-06942202258633</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010104</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:42.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202258626</udiDi>
    <basicUdiDi>B-06942202258626</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010104</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:26:41.409Z</lastUpdated>
  </row>
</eudamedExport>