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<eudamedExport entity="devices">
  <row>
    <udiDi>06942202238727</udiDi>
    <basicUdiDi>B-06942202238727</basicUdiDi>
    <tradeName>DIRUI</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>3014888</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:15.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238710</udiDi>
    <basicUdiDi>B-06942202238710</basicUdiDi>
    <tradeName>DIRUI</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>3014908</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:14.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238703</udiDi>
    <basicUdiDi>B-06942202238703</basicUdiDi>
    <tradeName>DIRUI</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>3014556</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:13.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238697</udiDi>
    <basicUdiDi>B-06942202238697</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012186</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:12.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238680</udiDi>
    <basicUdiDi>B-06942202238680</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012488</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:06.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238673</udiDi>
    <basicUdiDi>B-06942202238673</basicUdiDi>
    <tradeName>High Sensitivity C-Reactive Protein Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016294</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:05.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238666</udiDi>
    <basicUdiDi>B-06942202238666</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009798</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:03.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238659</udiDi>
    <basicUdiDi>B-06942202238659</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009796</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:14:01.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238642</udiDi>
    <basicUdiDi>B-06942202238642</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>High Sensitivity C-Reactive Protein 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>W01021308</emdnCode>
    <emdnDescription>HIGH-SENSITIVITY C-.REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009794</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:55.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238635</udiDi>
    <basicUdiDi>B-06942202238635</basicUdiDi>
    <tradeName>DIRUI</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>3014892</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:54.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238628</udiDi>
    <basicUdiDi>B-06942202238628</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>COMPLEMENT3 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>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014881</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:52.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238611</udiDi>
    <basicUdiDi>B-06942202238611</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012801</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:51.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238604</udiDi>
    <basicUdiDi>B-06942202238604</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012827</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:44.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238598</udiDi>
    <basicUdiDi>B-06942202238598</basicUdiDi>
    <tradeName>α2-macroglobulin Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011595</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:42.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238581</udiDi>
    <basicUdiDi>B-06942202238581</basicUdiDi>
    <tradeName>α2-macroglobulin Reagent Kit (Immunoturbidimetric Assay)</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011376</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:40.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238574</udiDi>
    <basicUdiDi>B-06942202238574</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011375</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:40.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238567</udiDi>
    <basicUdiDi>B-06942202238567</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α2-macroglobulin 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>W0102019003</emdnCode>
    <emdnDescription>A2-MACROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011374</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:33.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238550</udiDi>
    <basicUdiDi>B-06942202238550</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-acid Glycoprotein 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>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012940</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:32.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238543</udiDi>
    <basicUdiDi>B-06942202238543</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-acid Glycoprotein 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>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012952</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:31.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238536</udiDi>
    <basicUdiDi>B-06942202238536</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>α1-acid Glycoprotein 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>W0102019001</emdnCode>
    <emdnDescription>A1-ACID GLYCOPROTEIN (OROSOMUCOID)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011644</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:13:30.191Z</lastUpdated>
  </row>
</eudamedExport>