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<eudamedExport entity="devices">
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    <udiDi>06925794581150</udiDi>
    <basicUdiDi>B-06925794581150</basicUdiDi>
    <tradeName>GLUCOSE REAGENT KIT(GLUCOSE OXIDASE METHOD)</tradeName>
    <deviceName>GLUCOSE REAGENT KIT(GLUCOSE OXIDASE 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>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019371</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:38.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581143</udiDi>
    <basicUdiDi>B-06925794581143</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>3019396</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:37.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794581136</udiDi>
    <basicUdiDi>B-06925794581136</basicUdiDi>
    <tradeName>CREATININE REAGENT KIT（ENZYME METHOD）</tradeName>
    <deviceName>CREATININE 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>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019459</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:41:36.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574879</udiDi>
    <basicUdiDi>B-06925794574879</basicUdiDi>
    <tradeName>Pyruvate Reagent Kit (Lactate Dehydrogenase Assay)</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:45.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574862</udiDi>
    <basicUdiDi>B-06925794574862</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019853</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:44.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574855</udiDi>
    <basicUdiDi>B-06925794574855</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019832</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:43.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574848</udiDi>
    <basicUdiDi>B-06925794574848</basicUdiDi>
    <tradeName>Pyruvate Reagent Kit (Lactate Dehydrogenase Assay)</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:42.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574831</udiDi>
    <basicUdiDi>B-06925794574831</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019819</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:38.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574824</udiDi>
    <basicUdiDi>B-06925794574824</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Pyruvate 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>W01010226</emdnCode>
    <emdnDescription>PYRUVATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019794</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:37.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574817</udiDi>
    <basicUdiDi>B-06925794574817</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019842</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:36.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574800</udiDi>
    <basicUdiDi>B-06925794574800</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019792</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:35.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574794</udiDi>
    <basicUdiDi>B-06925794574794</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019791</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:31.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574787</udiDi>
    <basicUdiDi>B-06925794574787</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019831</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:30.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574770</udiDi>
    <basicUdiDi>B-06925794574770</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019818</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:30.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794574763</udiDi>
    <basicUdiDi>B-06925794574763</basicUdiDi>
    <tradeName>DIRUI</tradeName>
    <deviceName>Ammonia Reagent Kit (Glutamate Dehydrogase 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>3019841</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:39:29.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794520173</udiDi>
    <basicUdiDi>B-06925794520173</basicUdiDi>
    <tradeName>Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013826</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:36:12.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794511805</udiDi>
    <basicUdiDi>B-06925794511805</basicUdiDi>
    <tradeName>Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Thyroglobulin Detection Kit (Chemiluminescence Immunoassay)</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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3008737</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:29:28.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921807610282</udiDi>
    <basicUdiDi>B-06921807610282</basicUdiDi>
    <tradeName>Uric Acid Test Strip</tradeName>
    <deviceName>Uric Acid Test Strips</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL0425</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:28.549Z</lastUpdated>
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    <udiDi>05907514694709</udiDi>
    <basicUdiDi>B-05907514694709</basicUdiDi>
    <tradeName>OS-CREA ENZYMATIC</tradeName>
    <deviceName>CREA ENZYMATIC</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-470</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:18:14.714Z</lastUpdated>
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    <udiDi>05907514694617</udiDi>
    <basicUdiDi>B-05907514694617</basicUdiDi>
    <tradeName>OS-LACTATE</tradeName>
    <deviceName>LACTATE</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010218</emdnCode>
    <emdnDescription>LACTATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-461</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:18:09.928Z</lastUpdated>
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