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<eudamedExport entity="devices">
  <row>
    <udiDi>06942202240959</udiDi>
    <basicUdiDi>B-06942202240959</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>3000583</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:59.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240942</udiDi>
    <basicUdiDi>B-06942202240942</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC 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>3012501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:57.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240935</udiDi>
    <basicUdiDi>B-06942202240935</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC 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>3004412</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:57.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240928</udiDi>
    <basicUdiDi>B-06942202240928</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>MICROALBUMIN 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012541</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:55.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240911</udiDi>
    <basicUdiDi>B-06942202240911</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>MICROALBUMIN 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004624</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:49.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240904</udiDi>
    <basicUdiDi>B-06942202240904</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>MICROALBUMIN 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>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001070</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:48.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240898</udiDi>
    <basicUdiDi>B-06942202240898</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>UREA 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>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000622</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:47.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240881</udiDi>
    <basicUdiDi>B-06942202240881</basicUdiDi>
    <tradeName>TOTAL PROTEIN REAGENT KIT (BIURET METHOD)</tradeName>
    <deviceName>TOTAL PROTEIN REAGENT KIT (BIURET 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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000526</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:46.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240874</udiDi>
    <basicUdiDi>B-06942202240874</basicUdiDi>
    <tradeName>DIRUI</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>3002324</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:40.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240867</udiDi>
    <basicUdiDi>B-06942202240867</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>3000503</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:38.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240850</udiDi>
    <basicUdiDi>B-06942202240850</basicUdiDi>
    <tradeName>DIRUI</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>3000429</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:37.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240843</udiDi>
    <basicUdiDi>B-06942202240843</basicUdiDi>
    <tradeName>DIRUI</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>3000443</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:36.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240744</udiDi>
    <basicUdiDi>B-06942202240744</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010104</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:30.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240737</udiDi>
    <basicUdiDi>B-06942202240737</basicUdiDi>
    <tradeName>Auto-Chemistry Analyzer</tradeName>
    <deviceName>Auto-Chemistry Analyzer</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>W0201010104</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - HIGH ROUTINE (Random access without ISE mode test/h &gt; 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:29.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239984</udiDi>
    <basicUdiDi>B-06942202239984</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Sialic Acid 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>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015843</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:28.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239977</udiDi>
    <basicUdiDi>B-06942202239977</basicUdiDi>
    <tradeName>DIRUI</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>3019752</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:26.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239960</udiDi>
    <basicUdiDi>B-06942202239960</basicUdiDi>
    <tradeName>DIRUI</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>3019747</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:20.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239953</udiDi>
    <basicUdiDi>B-06942202239953</basicUdiDi>
    <tradeName>DIRUI</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>3019746</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:19.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239946</udiDi>
    <basicUdiDi>B-06942202239946</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>3014906</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:18.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202239939</udiDi>
    <basicUdiDi>B-06942202239939</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>LIPASE REAGENT KIT (COLORIMETRIC 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>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014187</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:19:17.108Z</lastUpdated>
  </row>
</eudamedExport>