<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202238529</udiDi>
    <basicUdiDi>B-06942202238529</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-acid Glycoprotein 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>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011451</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:23.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238512</udiDi>
    <basicUdiDi>B-06942202238512</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-antitrypsin 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>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012892</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:21.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238505</udiDi>
    <basicUdiDi>B-06942202238505</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-antitrypsin 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>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012981</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:20.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238499</udiDi>
    <basicUdiDi>B-06942202238499</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-antitrypsin 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>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011711</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:18.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238482</udiDi>
    <basicUdiDi>B-06942202238482</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-antitrypsin 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>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:12.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238475</udiDi>
    <basicUdiDi>B-06942202238475</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016181</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:10.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238468</udiDi>
    <basicUdiDi>B-06942202238468</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014555</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:08.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238451</udiDi>
    <basicUdiDi>B-06942202238451</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3012826</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:07.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238444</udiDi>
    <basicUdiDi>B-06942202238444</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3012984</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:01.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238437</udiDi>
    <basicUdiDi>B-06942202238437</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3011822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:58.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238420</udiDi>
    <basicUdiDi>B-06942202238420</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3011749</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:57.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238413</udiDi>
    <basicUdiDi>B-06942202238413</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3011407</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:56.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238406</udiDi>
    <basicUdiDi>B-06942202238406</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(GLUCOSE OXIDASE 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012533</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:50.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238390</udiDi>
    <basicUdiDi>B-06942202238390</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(GLUCOSE OXIDASE 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000603</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:49.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238383</udiDi>
    <basicUdiDi>B-06942202238383</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(HEXOKINASE 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012233</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:48.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238376</udiDi>
    <basicUdiDi>B-06942202238376</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(HEXOKINASE 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000582</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:46.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238369</udiDi>
    <basicUdiDi>B-06942202238369</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION 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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016175</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:40.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238352</udiDi>
    <basicUdiDi>B-06942202238352</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION 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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016168</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:39.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238345</udiDi>
    <basicUdiDi>B-06942202238345</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012976</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:38.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238338</udiDi>
    <basicUdiDi>B-06942202238338</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>β-Hydroxybutyrate Reagent Kit（β-hydroxybutyrate 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013025</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:12:37.259Z</lastUpdated>
  </row>
</eudamedExport>