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<eudamedExport entity="devices">
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    <udiDi>06942202261497</udiDi>
    <basicUdiDi>B-06942202261497</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013338</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:38:02.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261480</udiDi>
    <basicUdiDi>B-06942202261480</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002410</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:38:01.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261473</udiDi>
    <basicUdiDi>B-06942202261473</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013344</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:59.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261466</udiDi>
    <basicUdiDi>B-06942202261466</basicUdiDi>
    <tradeName>ISE Reference Solution</tradeName>
    <deviceName>ISE Reference Solution</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>W01010399</emdnCode>
    <emdnDescription>ELECTROLYTES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001230</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:53.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261367</udiDi>
    <basicUdiDi>B-06942202261367</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>3016007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:52.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261350</udiDi>
    <basicUdiDi>B-06942202261350</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>3012545</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:51.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261343</udiDi>
    <basicUdiDi>B-06942202261343</basicUdiDi>
    <tradeName>MAGNESIUM REAGENT KIT（XYLIDYL BLUE METHOD）</tradeName>
    <deviceName>MAGNESIUM REAGENT KIT（XYLIDYL BLUE 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>3000867</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:50.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261336</udiDi>
    <basicUdiDi>B-06942202261336</basicUdiDi>
    <tradeName>Fe REAGENT KIT (FERENE METHOD)</tradeName>
    <deviceName>Fe REAGENT KIT (FERENE 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>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002860</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:44.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261329</udiDi>
    <basicUdiDi>B-06942202261329</basicUdiDi>
    <tradeName>CALCIUM REAGENT KIT（CRESOLPHTHALEIN COMPLEXONE METHOD）</tradeName>
    <deviceName>CALCIUM REAGENT KIT（CRESOLPHTHALEIN COMPLEXONE 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>3000822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:43.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261312</udiDi>
    <basicUdiDi>B-06942202261312</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>3000837</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:41.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261305</udiDi>
    <basicUdiDi>B-06942202261305</basicUdiDi>
    <tradeName>Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Heart Fatty Acid-Binding Protein Reagent 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>W01021302</emdnCode>
    <emdnDescription>HEART-TYPE FATTY ACID BINDING PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012903</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:40.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261299</udiDi>
    <basicUdiDi>B-06942202261299</basicUdiDi>
    <tradeName>Glycated Albumin Reagent Kit (Ketamine Oxidase Assay)</tradeName>
    <deviceName>Glycated Albumin Reagent Kit (Ketamine Oxidase 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>3012809</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:34.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261282</udiDi>
    <basicUdiDi>B-06942202261282</basicUdiDi>
    <tradeName>ADENOSINE DEAMINASE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>ADENOSINE DEAMINASE REAGENT KIT（ENZYME 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>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002931</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:33.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261275</udiDi>
    <basicUdiDi>B-06942202261275</basicUdiDi>
    <tradeName>AMYLASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>AMYLASE 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000812</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:32.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261268</udiDi>
    <basicUdiDi>B-06942202261268</basicUdiDi>
    <tradeName>AMYLASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>AMYLASE 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:31.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261251</udiDi>
    <basicUdiDi>B-06942202261251</basicUdiDi>
    <tradeName>AMYLASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>AMYLASE 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016503</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:24.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261244</udiDi>
    <basicUdiDi>B-06942202261244</basicUdiDi>
    <tradeName>AMYLASE REAGENT KIT（IFCC METHOD）</tradeName>
    <deviceName>AMYLASE 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>W01010108</emdnCode>
    <emdnDescription>AMYLASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3016499</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:23.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261237</udiDi>
    <basicUdiDi>B-06942202261237</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>LIPOPROTEIN (a) 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021156</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:22.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261220</udiDi>
    <basicUdiDi>B-06942202261220</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>LIPOPROTEIN (a) 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003007</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:21.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202261213</udiDi>
    <basicUdiDi>B-06942202261213</basicUdiDi>
    <tradeName>LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>LIPOPROTEIN (a) 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>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3014896</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T12:37:15.347Z</lastUpdated>
  </row>
</eudamedExport>