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<eudamedExport entity="devices">
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    <udiDi>06942202246869</udiDi>
    <basicUdiDi>B-06942202246869</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>232013502006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:17.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246852</udiDi>
    <basicUdiDi>B-06942202246852</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN M KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>IMMUNOGLOBULIN M KIT（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>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020302006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:13.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246845</udiDi>
    <basicUdiDi>B-06942202246845</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN G KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>IMMUNOGLOBULIN G KIT（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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020202006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:12.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246838</udiDi>
    <basicUdiDi>B-06942202246838</basicUdiDi>
    <tradeName>IMMUNOGLOBULIN A KIT (IMMUNOTURBIDIMETRIC METHOD)</tradeName>
    <deviceName>IMMUNOGLOBULIN A KIT (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>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020102006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:11.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246821</udiDi>
    <basicUdiDi>B-06942202246821</basicUdiDi>
    <tradeName>RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>RHEUMATOID FACTOR 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>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020802006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:11.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246791</udiDi>
    <basicUdiDi>B-06942202246791</basicUdiDi>
    <tradeName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT4 REAGENT KIT（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>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020602006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:06.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246784</udiDi>
    <basicUdiDi>B-06942202246784</basicUdiDi>
    <tradeName>COMPLEMENT3 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT3 REAGENT KIT（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>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:06.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246814</udiDi>
    <basicUdiDi>B-06942202246814</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>3004620</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:05.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246807</udiDi>
    <basicUdiDi>B-06942202246807</basicUdiDi>
    <tradeName>COMPLEMENT4 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT4 REAGENT KIT（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>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004607</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:15:04.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246777</udiDi>
    <basicUdiDi>B-06942202246777</basicUdiDi>
    <tradeName>COMPLEMENT3 REAGENT KIT（IMMUNOTURBIDIMETRIC METHOD）</tradeName>
    <deviceName>COMPLEMENT3 REAGENT KIT（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>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232020502006</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:47.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246760</udiDi>
    <basicUdiDi>B-06942202246760</basicUdiDi>
    <tradeName>C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）</tradeName>
    <deviceName>C-REACTIVE PROTEIN 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>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232021602032</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:46.916Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246753</udiDi>
    <basicUdiDi>B-06942202246753</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3012188</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:46.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246746</udiDi>
    <basicUdiDi>B-06942202246746</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009804</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:45.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246739</udiDi>
    <basicUdiDi>B-06942202246739</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009802</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:41.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246722</udiDi>
    <basicUdiDi>B-06942202246722</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3009800</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:40.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246715</udiDi>
    <basicUdiDi>B-06942202246715</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</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>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004702</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:39.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246708</udiDi>
    <basicUdiDi>B-06942202246708</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>3011486</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:38.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246692</udiDi>
    <basicUdiDi>B-06942202246692</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>232011902001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:34.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246685</udiDi>
    <basicUdiDi>B-06942202246685</basicUdiDi>
    <tradeName>FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION METHOD)</tradeName>
    <deviceName>FRUCTOSAMINE REAGENT KIT ( NITROTETRAZOLIUM-BLUE REDUCTION 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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>232013702008</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:34.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202246678</udiDi>
    <basicUdiDi>B-06942202246678</basicUdiDi>
    <tradeName>Neutrophil Gelatinase-associated Lipocalin Reagent Kit (Latex Immunoturbidimetric Assay)</tradeName>
    <deviceName>Neutrophil Gelatinase-associated Lipocalin 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>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3011847</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T14:14:33.330Z</lastUpdated>
  </row>
</eudamedExport>