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<eudamedExport entity="devices">
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    <udiDi>06925794511812</udiDi>
    <basicUdiDi>B-06925794511812</basicUdiDi>
    <tradeName>Thyroxine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroxine 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>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008740</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:29.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511805</udiDi>
    <basicUdiDi>B-06925794511805</basicUdiDi>
    <tradeName>Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroglobulin 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:28.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511799</udiDi>
    <basicUdiDi>B-06925794511799</basicUdiDi>
    <tradeName>Free Thyroxine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Thyroxine 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>W01020402</emdnCode>
    <emdnDescription>FREE THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008734</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:26.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511782</udiDi>
    <basicUdiDi>B-06925794511782</basicUdiDi>
    <tradeName>Estradiol Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Estradiol 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>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008731</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:24.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511775</udiDi>
    <basicUdiDi>B-06925794511775</basicUdiDi>
    <tradeName>Free Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Free Triiodothyronine 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>W01020401</emdnCode>
    <emdnDescription>FREE TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008728</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:22.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511768</udiDi>
    <basicUdiDi>B-06925794511768</basicUdiDi>
    <tradeName>Triiodothyronine Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Triiodothyronine 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>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008725</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:22.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511751</udiDi>
    <basicUdiDi>B-06925794511751</basicUdiDi>
    <tradeName>Progesterone Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Progesterone 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>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008722</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:20.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511744</udiDi>
    <basicUdiDi>B-06925794511744</basicUdiDi>
    <tradeName>Follicle Stimulating Hormone Detection Kit  (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Follicle Stimulating Hormone 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>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008719</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:18.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511737</udiDi>
    <basicUdiDi>B-06925794511737</basicUdiDi>
    <tradeName>Prolactin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Prolactin 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>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008716</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:16.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794505965</udiDi>
    <basicUdiDi>B-06925794505965</basicUdiDi>
    <tradeName>Calibrator for Automatic Hematology Analyzer (5-part)</tradeName>
    <deviceName>Calibrator for Automatic Hematology Analyzer (5-part)</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0103010507</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:15.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794505286</udiDi>
    <basicUdiDi>B-06925794505286</basicUdiDi>
    <tradeName>Kit for Urine Sediment Analyzer</tradeName>
    <deviceName>Kit for Urine Sediment 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>W010106020302</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232030203201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:14.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504944</udiDi>
    <basicUdiDi>B-06925794504944</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-6800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:11.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794505033</udiDi>
    <basicUdiDi>B-06925794505033</basicUdiDi>
    <tradeName>Urinalysis Control</tradeName>
    <deviceName>Urinalysis 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>232030301201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:10.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794505019</udiDi>
    <basicUdiDi>B-06925794505019</basicUdiDi>
    <tradeName>Urinalysis Control</tradeName>
    <deviceName>Urinalysis 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>232030303201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:09.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504906</udiDi>
    <basicUdiDi>B-06925794504906</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-3600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:07.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504753</udiDi>
    <basicUdiDi>B-06925794504753</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>W0201010107</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h &gt; 800 and &lt;= 1.200)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-1300B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:28:53.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504562</udiDi>
    <basicUdiDi>B-06925794504562</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-2000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:28:51.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504517</udiDi>
    <basicUdiDi>B-06925794504517</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-800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:28:46.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504340</udiDi>
    <basicUdiDi>B-06925794504340</basicUdiDi>
    <tradeName>Control for Hematology Analyzer</tradeName>
    <deviceName>Control for 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>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232030507202</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:28:45.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794504333</udiDi>
    <basicUdiDi>B-06925794504333</basicUdiDi>
    <tradeName>Control for Hematology Analyzer</tradeName>
    <deviceName>Control for 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>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232030507201</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:28:44.763Z</lastUpdated>
  </row>
</eudamedExport>