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<eudamedExport entity="devices">
  <row>
    <udiDi>06925794516718</udiDi>
    <basicUdiDi>B-06925794516718</basicUdiDi>
    <tradeName>FE ControlⅡPositive Control</tradeName>
    <deviceName>FE ControlⅡPositive Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009389</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:44.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516688</udiDi>
    <basicUdiDi>B-06925794516688</basicUdiDi>
    <tradeName>FE CalibratorⅡ</tradeName>
    <deviceName>FE CalibratorⅡ</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009399</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:43.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516671</udiDi>
    <basicUdiDi>B-06925794516671</basicUdiDi>
    <tradeName>FE Focus B II</tradeName>
    <deviceName>FE Focus B II</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009374</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:43.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516664</udiDi>
    <basicUdiDi>B-06925794516664</basicUdiDi>
    <tradeName>FE ControlⅡNegative Control</tradeName>
    <deviceName>FE ControlⅡNegative Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009393</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:39.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516657</udiDi>
    <basicUdiDi>B-06925794516657</basicUdiDi>
    <tradeName>FE ControlⅡPositive Control</tradeName>
    <deviceName>FE ControlⅡPositive Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009388</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:38.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516626</udiDi>
    <basicUdiDi>B-06925794516626</basicUdiDi>
    <tradeName>FE CalibratorⅡ</tradeName>
    <deviceName>FE CalibratorⅡ</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009398</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516619</udiDi>
    <basicUdiDi>B-06925794516619</basicUdiDi>
    <tradeName>FE Focus B II</tradeName>
    <deviceName>FE Focus B II</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009373</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:36.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516374</udiDi>
    <basicUdiDi>B-06925794516374</basicUdiDi>
    <tradeName>C-REACTIVE PROTEIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY)</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>3009261</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:32.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794516367</udiDi>
    <basicUdiDi>B-06925794516367</basicUdiDi>
    <tradeName>C-REACTIVE PROTEIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY)</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>3009265</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:31.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794515124</udiDi>
    <basicUdiDi>B-06925794515124</basicUdiDi>
    <tradeName>Urine Conductivity Analysis Control</tradeName>
    <deviceName>Urine Conductivity Analysis Control</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008160</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:31.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794515063</udiDi>
    <basicUdiDi>B-06925794515063</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology 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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-6900CRP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:30.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794515049</udiDi>
    <basicUdiDi>B-06925794515049</basicUdiDi>
    <tradeName>Urinalysis Hybrid</tradeName>
    <deviceName>Urinalysis Hybrid</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>FUS-1000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:26.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794515032</udiDi>
    <basicUdiDi>B-06925794515032</basicUdiDi>
    <tradeName>Urinalysis Hybrid</tradeName>
    <deviceName>Urinalysis Hybrid</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>FUS-3000Plus</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:25.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794515018</udiDi>
    <basicUdiDi>B-06925794515018</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology 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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-6900</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:24.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514981</udiDi>
    <basicUdiDi>B-06925794514981</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology 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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCC-3900</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:23.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514974</udiDi>
    <basicUdiDi>B-06925794514974</basicUdiDi>
    <tradeName>Automatic Hematology Analyzer</tradeName>
    <deviceName>Automatic Hematology 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>W0202010101</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 samples/hr)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-6960CRP</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:19.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514875</udiDi>
    <basicUdiDi>B-06925794514875</basicUdiDi>
    <tradeName>Urine Conductivity Analysis Calibrator</tradeName>
    <deviceName>Urine Conductivity Analysis Calibrator</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008146</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:19.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514424</udiDi>
    <basicUdiDi>B-06925794514424</basicUdiDi>
    <tradeName>Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 125 Detection Kit (Chemiluminescence Immunoassay)</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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:18.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514417</udiDi>
    <basicUdiDi>B-06925794514417</basicUdiDi>
    <tradeName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Alpha-fetoprotein Detection Kit (Chemiluminescence Immunoassay)</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>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:17.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794514400</udiDi>
    <basicUdiDi>B-06925794514400</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Cancer Antigen 15-3 Detection Kit (Chemiluminescence Immunoassay)</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008782</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:30:13.423Z</lastUpdated>
  </row>
</eudamedExport>