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<eudamedExport entity="devices">
  <row>
    <udiDi>06942202246982</udiDi>
    <basicUdiDi>B-06942202246982</basicUdiDi>
    <tradeName>MYOGLOBIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>MYOGLOBIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016165</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:12.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246975</udiDi>
    <basicUdiDi>B-06942202246975</basicUdiDi>
    <tradeName>α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC METHOD）</tradeName>
    <deviceName>α-HYDROXYBUTYRIC DEHYDROGENASE REAGENT KIT（DGKC 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>W01010118</emdnCode>
    <emdnDescription>HYDROXYBUTYRATE DEHYDROGENASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:11.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246968</udiDi>
    <basicUdiDi>B-06942202246968</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection Kit (Latex 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>3015064</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:10.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246951</udiDi>
    <basicUdiDi>B-06942202246951</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection Kit (Latex 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>3015078</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:08.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246944</udiDi>
    <basicUdiDi>B-06942202246944</basicUdiDi>
    <tradeName>D-Dimer Detection Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>D-Dimer Detection Kit (Latex 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>3015056</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:02.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246937</udiDi>
    <basicUdiDi>B-06942202246937</basicUdiDi>
    <tradeName>ZINC REAGENT KIT（COLORIMETRIC METHOD）</tradeName>
    <deviceName>ZINC 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>W01010233</emdnCode>
    <emdnDescription>ZINC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000892</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:23:01.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246920</udiDi>
    <basicUdiDi>B-06942202246920</basicUdiDi>
    <tradeName>Copper Reagent Kit (PAESA Chromogenic Agent Assay)</tradeName>
    <deviceName>Copper Reagent Kit (PAESA Chromogenic Agent 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>W01010206</emdnCode>
    <emdnDescription>COPPER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011909</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:59.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246913</udiDi>
    <basicUdiDi>B-06942202246913</basicUdiDi>
    <tradeName>Copper Reagent Kit (PAESA Chromogenic Agent Assay)</tradeName>
    <deviceName>Copper Reagent Kit (PAESA Chromogenic Agent 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>W01010206</emdnCode>
    <emdnDescription>COPPER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011769</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:58.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246906</udiDi>
    <basicUdiDi>B-06942202246906</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</tradeName>
    <deviceName>Sodium Reagent Kit(Galactosidase 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>3015967</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:52.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246890</udiDi>
    <basicUdiDi>B-06942202246890</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</tradeName>
    <deviceName>Sodium Reagent Kit(Galactosidase 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>3015852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:50.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246883</udiDi>
    <basicUdiDi>B-06942202246883</basicUdiDi>
    <tradeName>Sodium Reagent Kit(Galactosidase Assay)</tradeName>
    <deviceName>Sodium Reagent Kit(Galactosidase 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>3015966</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:49.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246876</udiDi>
    <basicUdiDi>B-06942202246876</basicUdiDi>
    <tradeName>CHLORIDE REAGENT KIT (THIOCYANATE METHOD)</tradeName>
    <deviceName>CHLORIDE REAGENT KIT (THIOCYANATE 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>3000847</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:48.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246869</udiDi>
    <basicUdiDi>B-06942202246869</basicUdiDi>
    <tradeName>CALCIUM REAGENT KIT (ARSENAZO III METHOD)</tradeName>
    <deviceName>CALCIUM REAGENT KIT (ARSENAZO III 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>3000836</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:42.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246852</udiDi>
    <basicUdiDi>B-06942202246852</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC 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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000956</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:41.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246845</udiDi>
    <basicUdiDi>B-06942202246845</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC 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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000943</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:40.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246838</udiDi>
    <basicUdiDi>B-06942202246838</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC METHOD)</tradeName>
    <deviceName>IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC 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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000930</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:38.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246821</udiDi>
    <basicUdiDi>B-06942202246821</basicUdiDi>
    <tradeName>RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>RHEUMATOID FACTOR 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:32.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246814</udiDi>
    <basicUdiDi>B-06942202246814</basicUdiDi>
    <tradeName>ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>ANTI-STREPTOLYSIN O 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>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004620</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:31.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246807</udiDi>
    <basicUdiDi>B-06942202246807</basicUdiDi>
    <tradeName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC 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>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004607</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:30.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246791</udiDi>
    <basicUdiDi>B-06942202246791</basicUdiDi>
    <tradeName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC 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>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000989</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:22:29.372Z</lastUpdated>
  </row>
</eudamedExport>