<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202238239</udiDi>
    <basicUdiDi>B-06942202238239</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>CREATININE 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012237</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:04:38.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238222</udiDi>
    <basicUdiDi>B-06942202238222</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232012202011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:04:34.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238123</udiDi>
    <basicUdiDi>B-06942202238123</basicUdiDi>
    <tradeName>N-ACETYL-β-D-GLUCOSAMINIDASE REAGENT KIT (MPT-NAG METHOD)</tradeName>
    <deviceName>N-ACETYL-β-D-GLUCOSAMINIDASE REAGENT KIT (MPT-NAG 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>3014897</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:04:22.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238116</udiDi>
    <basicUdiDi>B-06942202238116</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate 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>3013015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:04:21.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238000</udiDi>
    <basicUdiDi>B-06942202238000</basicUdiDi>
    <tradeName>DIRUI</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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012240</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:02:14.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237997</udiDi>
    <basicUdiDi>B-06942202237997</basicUdiDi>
    <tradeName>TOTAL PROTEIN REAGENT KIT (BIURET 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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232011102014</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:02:13.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237966</udiDi>
    <basicUdiDi>B-06942202237966</basicUdiDi>
    <tradeName>BILE ACID REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>BILE ACID 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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232011002012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:02:12.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237959</udiDi>
    <basicUdiDi>B-06942202237959</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Total Bilirubin Reagent Kit (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>3016491</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:02:11.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237942</udiDi>
    <basicUdiDi>B-06942202237942</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Total Bilirubin Reagent Kit (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>3015048</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:56.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237935</udiDi>
    <basicUdiDi>B-06942202237935</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL BILIRUBIN KIT（VANADATE OXIDATION 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>3012522</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:55.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237928</udiDi>
    <basicUdiDi>B-06942202237928</basicUdiDi>
    <tradeName>TOTAL BILIRUBIN KIT（VANADATE OXIDATION METHOD）</tradeName>
    <deviceName>TOTAL BILIRUBIN KIT（VANADATE OXIDATION 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>232010802108</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:54.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237911</udiDi>
    <basicUdiDi>B-06942202237911</basicUdiDi>
    <tradeName>DIRUI</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>3012493</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:53.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237904</udiDi>
    <basicUdiDi>B-06942202237904</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (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>3016490</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:49.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237898</udiDi>
    <basicUdiDi>B-06942202237898</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Direct Bilirubin Reagent Kit (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>3015070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:49.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237881</udiDi>
    <basicUdiDi>B-06942202237881</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION 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>3012514</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:48.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237874</udiDi>
    <basicUdiDi>B-06942202237874</basicUdiDi>
    <tradeName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION METHOD）</tradeName>
    <deviceName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION 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>232010902103</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:47.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237867</udiDi>
    <basicUdiDi>B-06942202237867</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>DIRECT BILIRUBIN REAGENT KIT(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>3012513</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:43.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237850</udiDi>
    <basicUdiDi>B-06942202237850</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>232011402011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:42.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237843</udiDi>
    <basicUdiDi>B-06942202237843</basicUdiDi>
    <tradeName>DIRUI</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>3012494</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:41.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202237836</udiDi>
    <basicUdiDi>B-06942202237836</basicUdiDi>
    <tradeName>DIRUI</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>3014884</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:01:41.062Z</lastUpdated>
  </row>
</eudamedExport>