<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>2026-08-03T14:14:13.330Z</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>2026-08-03T14:14:09.327Z</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>2026-08-03T14:14:08.512Z</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>2026-08-03T14:14:07.706Z</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>2026-08-03T14:14:06.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246494</udiDi>
    <basicUdiDi>B-06942202246494</basicUdiDi>
    <tradeName>Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011616</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:12:13.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246487</udiDi>
    <basicUdiDi>B-06942202246487</basicUdiDi>
    <tradeName>PREALBUMIN REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020402006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:12:12.430Z</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>2026-08-03T14:12:11.562Z</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>2026-08-03T14:12:10.877Z</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>2026-08-03T14:11:55.491Z</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>2026-08-03T14:11:54.689Z</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>2026-08-03T14:11:53.893Z</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>2026-08-03T14:11:53.083Z</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>2026-08-03T14:11:49.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246388</udiDi>
    <basicUdiDi>B-06942202246388</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>3004590</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:48.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246371</udiDi>
    <basicUdiDi>B-06942202246371</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>232014402002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:47.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244797</udiDi>
    <basicUdiDi>B-06942202244797</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) 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>3019751</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:42.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244780</udiDi>
    <basicUdiDi>B-06942202244780</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) 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>3019741</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:41.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244773</udiDi>
    <basicUdiDi>B-06942202244773</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) 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>3019756</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:41.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244766</udiDi>
    <basicUdiDi>B-06942202244766</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</tradeName>
    <deviceName>Homocysteine (HCY) 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>3019755</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:11:40.283Z</lastUpdated>
  </row>
</eudamedExport>