<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202213021</udiDi>
    <basicUdiDi>B-06942202213021</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>3023238</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:46:12.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212970</udiDi>
    <basicUdiDi>B-06942202212970</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>3023202</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:49.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212963</udiDi>
    <basicUdiDi>B-06942202212963</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>3023190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:48.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212956</udiDi>
    <basicUdiDi>B-06942202212956</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>3023189</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:47.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212949</udiDi>
    <basicUdiDi>B-06942202212949</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>3023188</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:45.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212857</udiDi>
    <basicUdiDi>B-06942202212857</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3023209</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:25.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202212840</udiDi>
    <basicUdiDi>B-06942202212840</basicUdiDi>
    <tradeName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN METHOD)</tradeName>
    <deviceName>ALBUMIN REAGENT KIT (BROMCRESOL GREEN 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>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3023229</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T13:45:25.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983155601</udiDi>
    <basicUdiDi>B-06936983155601</basicUdiDi>
    <tradeName>Cholesterol Test Strips</tradeName>
    <deviceName>Cholesterol Test Strips</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCHO-401/411</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:31:20.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306559</udiDi>
    <basicUdiDi>B-06936895306559</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:20mL×8（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:38.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306542</udiDi>
    <basicUdiDi>B-06936895306542</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:100ml×2（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:37.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306535</udiDi>
    <basicUdiDi>B-06936895306535</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:50ml×4（791）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:36.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306528</udiDi>
    <basicUdiDi>B-06936895306528</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:31.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306511</udiDi>
    <basicUdiDi>B-06936895306511</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:30.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306504</udiDi>
    <basicUdiDi>B-06936895306504</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（792）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:30.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306498</udiDi>
    <basicUdiDi>B-06936895306498</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:29.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306481</udiDi>
    <basicUdiDi>B-06936895306481</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（715）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:24.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306474</udiDi>
    <basicUdiDi>B-06936895306474</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:23.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306467</udiDi>
    <basicUdiDi>B-06936895306467</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:40mL×4（704）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:22.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306450</udiDi>
    <basicUdiDi>B-06936895306450</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:80mL×2（706）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:22.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895306443</udiDi>
    <basicUdiDi>B-06936895306443</basicUdiDi>
    <tradeName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</tradeName>
    <deviceName>Glycosylated Serum Proteins (GSP) Test Kit (Tetrazolium Blue)</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>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R:20mL×8（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:25:18.177Z</lastUpdated>
  </row>
</eudamedExport>