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<eudamedExport entity="devices">
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    <udiDi>06942202260803</udiDi>
    <basicUdiDi>B-06942202260803</basicUdiDi>
    <tradeName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000787</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:36.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260797</udiDi>
    <basicUdiDi>B-06942202260797</basicUdiDi>
    <tradeName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016529</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:34.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260780</udiDi>
    <basicUdiDi>B-06942202260780</basicUdiDi>
    <tradeName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016559</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:32.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260773</udiDi>
    <basicUdiDi>B-06942202260773</basicUdiDi>
    <tradeName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD）</tradeName>
    <deviceName>LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE 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>W01010119</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE L  ( LDH - L --&gt; P )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000789</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:26.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260766</udiDi>
    <basicUdiDi>B-06942202260766</basicUdiDi>
    <tradeName>Ischemic Modified Albumin Reagent Kit (ACB Assay)</tradeName>
    <deviceName>Ischemic Modified Albumin Reagent Kit (ACB 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>W01021399</emdnCode>
    <emdnDescription>CARDIAC MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011892</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:25.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260759</udiDi>
    <basicUdiDi>B-06942202260759</basicUdiDi>
    <tradeName>CREATINE KINASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000755</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:23.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260742</udiDi>
    <basicUdiDi>B-06942202260742</basicUdiDi>
    <tradeName>CREATINE KINASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012235</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:22.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260735</udiDi>
    <basicUdiDi>B-06942202260735</basicUdiDi>
    <tradeName>CREATINE KINASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016562</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:16.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260728</udiDi>
    <basicUdiDi>B-06942202260728</basicUdiDi>
    <tradeName>CREATINE KINASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016558</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:15.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260711</udiDi>
    <basicUdiDi>B-06942202260711</basicUdiDi>
    <tradeName>CREATINE KINASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>CREATINE KINASE REAGENT KIT（IFCC 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>W01010113</emdnCode>
    <emdnDescription>CREATINE KINASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000757</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:14.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260704</udiDi>
    <basicUdiDi>B-06942202260704</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3012553</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:11.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260698</udiDi>
    <basicUdiDi>B-06942202260698</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3012234</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:05.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260681</udiDi>
    <basicUdiDi>B-06942202260681</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3000775</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:04.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260674</udiDi>
    <basicUdiDi>B-06942202260674</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3016548</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:03.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260667</udiDi>
    <basicUdiDi>B-06942202260667</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3021167</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:35:02.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260650</udiDi>
    <basicUdiDi>B-06942202260650</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3021157</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:34:54.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260643</udiDi>
    <basicUdiDi>B-06942202260643</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3016519</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:34:53.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260636</udiDi>
    <basicUdiDi>B-06942202260636</basicUdiDi>
    <tradeName>CREATINE KINASE MB ISOENZYME REAGENT KIT（IMMUNOINHIBITION）</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>3000773</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:34:52.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260629</udiDi>
    <basicUdiDi>B-06942202260629</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>3012489</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:34:51.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202260612</udiDi>
    <basicUdiDi>B-06942202260612</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>3009768</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:34:45.284Z</lastUpdated>
  </row>
</eudamedExport>