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<eudamedExport entity="devices">
  <row>
    <udiDi>06942202246388</udiDi>
    <basicUdiDi>B-06942202246388</basicUdiDi>
    <tradeName>5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>5’-NUCLEOTIDASE 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>W01010101</emdnCode>
    <emdnDescription>5'-NUCLEOTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004590</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:47.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246371</udiDi>
    <basicUdiDi>B-06942202246371</basicUdiDi>
    <tradeName>5’-NUCLEOTIDASE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>5’-NUCLEOTIDASE 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>W01010101</emdnCode>
    <emdnDescription>5'-NUCLEOTIDASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001695</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:45.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202245473</udiDi>
    <basicUdiDi>B-06942202245473</basicUdiDi>
    <tradeName>Urinalysis System</tradeName>
    <deviceName>Urinalysis System</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MUS-9600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:44.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244797</udiDi>
    <basicUdiDi>B-06942202244797</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</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>3019751</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:43.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244780</udiDi>
    <basicUdiDi>B-06942202244780</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</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>3019741</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:37.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244773</udiDi>
    <basicUdiDi>B-06942202244773</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</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>3019756</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:36.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244766</udiDi>
    <basicUdiDi>B-06942202244766</basicUdiDi>
    <tradeName>Homocysteine (HCY) Reagent Kit (Enzymatic Cycling Method)</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>3019755</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:35.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202244049</udiDi>
    <basicUdiDi>B-06942202244049</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>2026-06-26T12:20:33.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202242717</udiDi>
    <basicUdiDi>B-06942202242717</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>3016059</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:27.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202242700</udiDi>
    <basicUdiDi>B-06942202242700</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>3015959</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:26.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202242694</udiDi>
    <basicUdiDi>B-06942202242694</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>HOMOCYSTEINE 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>3005502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:25.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202242229</udiDi>
    <basicUdiDi>B-06942202242229</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine 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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H-1600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:24.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202241031</udiDi>
    <basicUdiDi>B-06942202241031</basicUdiDi>
    <tradeName>DIRUI</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>3000692</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:18.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202241024</udiDi>
    <basicUdiDi>B-06942202241024</basicUdiDi>
    <tradeName>DIRUI</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>3003008</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:17.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202241017</udiDi>
    <basicUdiDi>B-06942202241017</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Fe REAGENT KIT (FERENE 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>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002857</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:16.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202241000</udiDi>
    <basicUdiDi>B-06942202241000</basicUdiDi>
    <tradeName>DIRUI</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>3000915</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:14.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240997</udiDi>
    <basicUdiDi>B-06942202240997</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012486</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:08.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240980</udiDi>
    <basicUdiDi>B-06942202240980</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001098</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:07.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240973</udiDi>
    <basicUdiDi>B-06942202240973</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>3004623</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:06.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202240966</udiDi>
    <basicUdiDi>B-06942202240966</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>3001058</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:20:05.134Z</lastUpdated>
  </row>
</eudamedExport>