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<eudamedExport entity="devices">
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    <udiDi>06942202238765</udiDi>
    <basicUdiDi>B-06942202238765</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>232013502001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:06:35.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202238741</udiDi>
    <basicUdiDi>B-06942202238741</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>232014802013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:06:30.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202228742</udiDi>
    <basicUdiDi>B-06942202228742</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Small Dense Low Density Lipoprotein-Cholesterol Reagent  Kit (Peroxidase Assay)</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:1×45mL	 R2:1×15mL		 Calibrator :1×1mL	 Control :1×1mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:57:36.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202215964</udiDi>
    <basicUdiDi>B-06942202215964</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>3023575</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:48:53.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202215957</udiDi>
    <basicUdiDi>B-06942202215957</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>3023542</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:48:49.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202215742</udiDi>
    <basicUdiDi>B-06942202215742</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>3023561</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:48:16.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202215735</udiDi>
    <basicUdiDi>B-06942202215735</basicUdiDi>
    <tradeName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC METHOD)</tradeName>
    <deviceName>CARBON DIOXIDE REAGENT KIT(ENZYMATIC 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>3023573</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:48:15.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213496</udiDi>
    <basicUdiDi>B-06942202213496</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>3023208</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:42.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213489</udiDi>
    <basicUdiDi>B-06942202213489</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>3023228</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:41.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213410</udiDi>
    <basicUdiDi>B-06942202213410</basicUdiDi>
    <tradeName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC METHOD)</tradeName>
    <deviceName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC 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>3023226</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:29.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213403</udiDi>
    <basicUdiDi>B-06942202213403</basicUdiDi>
    <tradeName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC METHOD)</tradeName>
    <deviceName>TOTAL PROTEIN IN URINE REAGENT KIT (TURBIDIMETRIC 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>3023257</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:28.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213274</udiDi>
    <basicUdiDi>B-06942202213274</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>3023205</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:09.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213267</udiDi>
    <basicUdiDi>B-06942202213267</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>3023214</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:47:08.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213175</udiDi>
    <basicUdiDi>B-06942202213175</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>3023220</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:46:37.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213168</udiDi>
    <basicUdiDi>B-06942202213168</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>3023211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:46:35.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213076</udiDi>
    <basicUdiDi>B-06942202213076</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>3023249</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:46:20.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202213069</udiDi>
    <basicUdiDi>B-06942202213069</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>3023241</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:46:19.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300861</udiDi>
    <basicUdiDi>B-06936895300861</basicUdiDi>
    <tradeName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality Control：1mL×2(92062)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:21:21.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300854</udiDi>
    <basicUdiDi>B-06936895300854</basicUdiDi>
    <tradeName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator：1mL×6(91069)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:21:21.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895300847</udiDi>
    <basicUdiDi>B-06936895300847</basicUdiDi>
    <tradeName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</tradeName>
    <deviceName>Serum Amyloid A Protein (SAA) Assay Test Kit  (Latex immune turbidity Method)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×5  R2:20mL×5(795)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:21:20.212Z</lastUpdated>
  </row>
</eudamedExport>