<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202246586</udiDi>
    <basicUdiDi>B-06942202246586</basicUdiDi>
    <tradeName>Haptoglobin Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Haptoglobin 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>W0102010302</emdnCode>
    <emdnDescription>HAPTOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011785</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:35.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246579</udiDi>
    <basicUdiDi>B-06942202246579</basicUdiDi>
    <tradeName>TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD)</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>3000476</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:34.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246562</udiDi>
    <basicUdiDi>B-06942202246562</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>3002325</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:32.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246555</udiDi>
    <basicUdiDi>B-06942202246555</basicUdiDi>
    <tradeName>ADENOSINE DEAMINASE REAGENT KIT（ENZYME METHOD）</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>3000567</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:31.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246548</udiDi>
    <basicUdiDi>B-06942202246548</basicUdiDi>
    <tradeName>Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Fibrin (Fibrinogen) Degradation Products 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>3015107</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:25.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246531</udiDi>
    <basicUdiDi>B-06942202246531</basicUdiDi>
    <tradeName>Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Fibrin (Fibrinogen) Degradation Products 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>3015120</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:24.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246524</udiDi>
    <basicUdiDi>B-06942202246524</basicUdiDi>
    <tradeName>Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Fibrin (Fibrinogen) Degradation Products 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>3015121</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:23.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246517</udiDi>
    <basicUdiDi>B-06942202246517</basicUdiDi>
    <tradeName>Fibrin (Fibrinogen) Degradation Products Detection Kit(Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Fibrin (Fibrinogen) Degradation Products 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>3015065</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:22.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246500</udiDi>
    <basicUdiDi>B-06942202246500</basicUdiDi>
    <tradeName>Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）</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>3011681</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:16.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246494</udiDi>
    <basicUdiDi>B-06942202246494</basicUdiDi>
    <tradeName>Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）</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>3011616</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:14.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246487</udiDi>
    <basicUdiDi>B-06942202246487</basicUdiDi>
    <tradeName>PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>PREALBUMIN 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>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:13.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246470</udiDi>
    <basicUdiDi>B-06942202246470</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>3001623</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:12.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246463</udiDi>
    <basicUdiDi>B-06942202246463</basicUdiDi>
    <tradeName>GLUTAMATE DEHYDROGENASE REAGENT KIT（THE IMPROVED DGKC METHOD）</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>3000555</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:06.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246456</udiDi>
    <basicUdiDi>B-06942202246456</basicUdiDi>
    <tradeName>Cholyglycine Reagent Kit (Homogeneous Enzyme Immunoassay )</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>3011515</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:05.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246449</udiDi>
    <basicUdiDi>B-06942202246449</basicUdiDi>
    <tradeName>Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )</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>3011582</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:03.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246432</udiDi>
    <basicUdiDi>B-06942202246432</basicUdiDi>
    <tradeName>Glycylproline Depeptidyl Aminopeptidase Reagent Kit (P-nitroaniline Assay )</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>3011531</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:21:02.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246425</udiDi>
    <basicUdiDi>B-06942202246425</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>3011708</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:56.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246418</udiDi>
    <basicUdiDi>B-06942202246418</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>3011445</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:55.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246401</udiDi>
    <basicUdiDi>B-06942202246401</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>3011687</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:54.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246395</udiDi>
    <basicUdiDi>B-06942202246395</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>3011623</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:53.183Z</lastUpdated>
  </row>
</eudamedExport>