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<eudamedExport entity="devices">
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    <udiDi>06925794593894</udiDi>
    <basicUdiDi>B-06925794593894</basicUdiDi>
    <tradeName>TOTAL IRON-BINDING CAPACITY REAGENT KIT (FERENE METHOD)</tradeName>
    <deviceName>TOTAL IRON-BINDING CAPACITY 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>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:30.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593887</udiDi>
    <basicUdiDi>B-06925794593887</basicUdiDi>
    <tradeName>TOTAL PROTEIN REAGENT KIT (BIURET METHOD)</tradeName>
    <deviceName>TOTAL PROTEIN REAGENT KIT (BIURET 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>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021670</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:29.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593870</udiDi>
    <basicUdiDi>B-06925794593870</basicUdiDi>
    <tradeName>BILE ACID REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>BILE ACID REAGENT KIT（ENZYMATIC CYCLING 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>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021738</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:25.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593863</udiDi>
    <basicUdiDi>B-06925794593863</basicUdiDi>
    <tradeName>TOTAL BILIRUBIN KIT（VANADATE OXIDATION METHOD）</tradeName>
    <deviceName>TOTAL BILIRUBIN KIT（VANADATE OXIDATION 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021733</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:24.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593856</udiDi>
    <basicUdiDi>B-06925794593856</basicUdiDi>
    <tradeName>TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT METHOD)</tradeName>
    <deviceName>TOTAL BILIRUBIN REAGENT KIT(SURFACTANT/DIAZO SALT 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021538</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:23.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593795</udiDi>
    <basicUdiDi>B-06925794593795</basicUdiDi>
    <tradeName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION METHOD）</tradeName>
    <deviceName>DIRECT BILIRUBIN KIT（VANADATE OXIDATION 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021731</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:13.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593788</udiDi>
    <basicUdiDi>B-06925794593788</basicUdiDi>
    <tradeName>DIRECT BILIRUBIN REAGENT KIT(DIAZO SALT METHOD)</tradeName>
    <deviceName>DIRECT BILIRUBIN REAGENT KIT(DIAZO SALT 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>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021559</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:51:11.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593610</udiDi>
    <basicUdiDi>B-06925794593610</basicUdiDi>
    <tradeName>Free Fatty Acid Reagent Kit (ACS-ACOD Assay)</tradeName>
    <deviceName>Free Fatty Acid Reagent Kit (ACS-ACOD 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>3021585</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:32.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593603</udiDi>
    <basicUdiDi>B-06925794593603</basicUdiDi>
    <tradeName>Free Fatty Acid Reagent Kit (ACS-ACOD Assay)</tradeName>
    <deviceName>Free Fatty Acid Reagent Kit (ACS-ACOD 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>3021613</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:31.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593559</udiDi>
    <basicUdiDi>B-06925794593559</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>3021693</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:24.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593467</udiDi>
    <basicUdiDi>B-06925794593467</basicUdiDi>
    <tradeName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV METHOD)</tradeName>
    <deviceName>INORGANIC PHOSPHORUS REAGENT KIT(DIRECT UV 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>3021605</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:06.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593450</udiDi>
    <basicUdiDi>B-06925794593450</basicUdiDi>
    <tradeName>Sialic Acid Reagent Kit（Lactate Dehydrogenase Assay）</tradeName>
    <deviceName>Sialic Acid Reagent Kit（Lactate Dehydrogenase 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>3021551</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:06.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593443</udiDi>
    <basicUdiDi>B-06925794593443</basicUdiDi>
    <tradeName>Sialic Acid Reagent Kit（Lactate Dehydrogenase Assay）</tradeName>
    <deviceName>Sialic Acid Reagent Kit（Lactate Dehydrogenase 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>3021716</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:50:05.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593436</udiDi>
    <basicUdiDi>B-06925794593436</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021579</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:53.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593429</udiDi>
    <basicUdiDi>B-06925794593429</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>3021529</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:48.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593412</udiDi>
    <basicUdiDi>B-06925794593412</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>3021604</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:47.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593405</udiDi>
    <basicUdiDi>B-06925794593405</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>3021550</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:46.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593399</udiDi>
    <basicUdiDi>B-06925794593399</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>3021603</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:46.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593382</udiDi>
    <basicUdiDi>B-06925794593382</basicUdiDi>
    <tradeName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING METHOD）</tradeName>
    <deviceName>HOMOCYSTEINE REAGENT KIT（ENZYMATIC CYCLING 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>3021715</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:42.055Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794593368</udiDi>
    <basicUdiDi>B-06925794593368</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>3021549</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:40.453Z</lastUpdated>
  </row>
</eudamedExport>