<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202261206</udiDi>
    <basicUdiDi>B-06942202261206</basicUdiDi>
    <tradeName>Apolipoprotein E Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein E 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>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012970</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:14.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261190</udiDi>
    <basicUdiDi>B-06942202261190</basicUdiDi>
    <tradeName>Apolipoprotein C2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein C2 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>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012770</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:12.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261183</udiDi>
    <basicUdiDi>B-06942202261183</basicUdiDi>
    <tradeName>APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012531</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:11.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261176</udiDi>
    <basicUdiDi>B-06942202261176</basicUdiDi>
    <tradeName>APOLIPOPROTEIN B REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN B 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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021178</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:05.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261169</udiDi>
    <basicUdiDi>B-06942202261169</basicUdiDi>
    <tradeName>Apolipoprotein A2 Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>Apolipoprotein A2 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>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012793</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:04.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261152</udiDi>
    <basicUdiDi>B-06942202261152</basicUdiDi>
    <tradeName>APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN A1 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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012524</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:03.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261145</udiDi>
    <basicUdiDi>B-06942202261145</basicUdiDi>
    <tradeName>APOLIPOPROTEIN A1 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>APOLIPOPROTEIN A1 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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021155</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:02.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261138</udiDi>
    <basicUdiDi>B-06942202261138</basicUdiDi>
    <tradeName>Free Fatty Acid Reagent Kit (ACS-ACOD Assay)</tradeName>
    <deviceName>Free Fatty Acid Reagent Kit (ACS-ACOD 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>3012810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:56.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261121</udiDi>
    <basicUdiDi>B-06942202261121</basicUdiDi>
    <tradeName>Phospholipid Reagent Kit (Choline Oxide Assay)</tradeName>
    <deviceName>Phospholipid Reagent Kit (Choline Oxide 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>W01010224</emdnCode>
    <emdnDescription>PHOSPHOLIPIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013019</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:54.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261114</udiDi>
    <basicUdiDi>B-06942202261114</basicUdiDi>
    <tradeName>Phospholipid Reagent Kit (Choline Oxide Assay)</tradeName>
    <deviceName>Phospholipid Reagent Kit (Choline Oxide 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>W01010224</emdnCode>
    <emdnDescription>PHOSPHOLIPIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011803</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:53.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261107</udiDi>
    <basicUdiDi>B-06942202261107</basicUdiDi>
    <tradeName>Phospholipid Reagent Kit (Choline Oxide Assay)</tradeName>
    <deviceName>Phospholipid Reagent Kit (Choline Oxide 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>W01010224</emdnCode>
    <emdnDescription>PHOSPHOLIPIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011540</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:52.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261091</udiDi>
    <basicUdiDi>B-06942202261091</basicUdiDi>
    <tradeName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000724</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:46.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261084</udiDi>
    <basicUdiDi>B-06942202261084</basicUdiDi>
    <tradeName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016526</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:45.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261077</udiDi>
    <basicUdiDi>B-06942202261077</basicUdiDi>
    <tradeName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021192</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:44.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261060</udiDi>
    <basicUdiDi>B-06942202261060</basicUdiDi>
    <tradeName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016521</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:42.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261053</udiDi>
    <basicUdiDi>B-06942202261053</basicUdiDi>
    <tradeName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT 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>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000726</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:36.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261046</udiDi>
    <basicUdiDi>B-06942202261046</basicUdiDi>
    <tradeName>TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD）</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000707</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:35.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261039</udiDi>
    <basicUdiDi>B-06942202261039</basicUdiDi>
    <tradeName>TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD）</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016523</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:34.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261022</udiDi>
    <basicUdiDi>B-06942202261022</basicUdiDi>
    <tradeName>TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD）</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021180</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:33.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261015</udiDi>
    <basicUdiDi>B-06942202261015</basicUdiDi>
    <tradeName>TRIGLYCERIDES REAGENT KIT（OXIDASE METHOD）</tradeName>
    <deviceName>TRIGLYCERIDES REAGENT KIT（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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016552</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:36:27.317Z</lastUpdated>
  </row>
</eudamedExport>