<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925794581310</udiDi>
    <basicUdiDi>B-06925794581310</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>3019461</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:44:02.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581303</udiDi>
    <basicUdiDi>B-06925794581303</basicUdiDi>
    <tradeName>AMYLASE REAGENT KIT（IFCC 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019460</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:42:09.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581297</udiDi>
    <basicUdiDi>B-06925794581297</basicUdiDi>
    <tradeName>MAGNESIUM REAGENT KIT（XYLIDYL BLUE 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019350</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:42:09.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581266</udiDi>
    <basicUdiDi>B-06925794581266</basicUdiDi>
    <tradeName>ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC 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>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019374</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:42:09.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581259</udiDi>
    <basicUdiDi>B-06925794581259</basicUdiDi>
    <tradeName>CHOLESTEROL REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CHOLESTEROL 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>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:42:08.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581242</udiDi>
    <basicUdiDi>B-06925794581242</basicUdiDi>
    <tradeName>LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD）</tradeName>
    <deviceName>LOW 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>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019432</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:51.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581235</udiDi>
    <basicUdiDi>B-06925794581235</basicUdiDi>
    <tradeName>ALKALINE PHOSPHATASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>ALKALINE PHOSPHATASE REAGENT KIT（IFCC 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>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019446</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:51.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581211</udiDi>
    <basicUdiDi>B-06925794581211</basicUdiDi>
    <tradeName>URIC ACID REAGENT KIT（URICASE METHOD）</tradeName>
    <deviceName>URIC ACID REAGENT KIT（URICASE 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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019372</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:49.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581204</udiDi>
    <basicUdiDi>B-06925794581204</basicUdiDi>
    <tradeName>GLUCOSE REAGENT KIT(HEXOKINASE METHOD)</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>3019431</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:45.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581198</udiDi>
    <basicUdiDi>B-06925794581198</basicUdiDi>
    <tradeName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>LACTATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019373</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:44.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581181</udiDi>
    <basicUdiDi>B-06925794581181</basicUdiDi>
    <tradeName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>γ-GLUTAMYL TRANSFERASE REAGENT KIT（IFCC 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>3019415</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:43.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581174</udiDi>
    <basicUdiDi>B-06925794581174</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>3019472</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:43.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581167</udiDi>
    <basicUdiDi>B-06925794581167</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</tradeName>
    <deviceName>CREATINE KINASE MB ISOENZYME 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>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019348</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:39.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581150</udiDi>
    <basicUdiDi>B-06925794581150</basicUdiDi>
    <tradeName>GLUCOSE REAGENT KIT(GLUCOSE OXIDASE METHOD)</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>3019371</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:38.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581143</udiDi>
    <basicUdiDi>B-06925794581143</basicUdiDi>
    <tradeName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV METHOD)</tradeName>
    <deviceName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV 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>3019396</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581136</udiDi>
    <basicUdiDi>B-06925794581136</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>3019459</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:36.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574879</udiDi>
    <basicUdiDi>B-06925794574879</basicUdiDi>
    <tradeName>Pyruvate Reagent Kit (Lactate Dehydrogenase Assay)</tradeName>
    <deviceName>Pyruvate Reagent Kit (Lactate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:45.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574862</udiDi>
    <basicUdiDi>B-06925794574862</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate Reagent Kit (Lactate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019853</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:44.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574855</udiDi>
    <basicUdiDi>B-06925794574855</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate Reagent Kit (Lactate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019832</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:43.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574848</udiDi>
    <basicUdiDi>B-06925794574848</basicUdiDi>
    <tradeName>Pyruvate Reagent Kit (Lactate Dehydrogenase Assay)</tradeName>
    <deviceName>Pyruvate Reagent Kit (Lactate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:42.874Z</lastUpdated>
  </row>
</eudamedExport>