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<eudamedExport entity="devices">
  <row>
    <udiDi>06947145584092</udiDi>
    <basicUdiDi>69471455587X6</basicUdiDi>
    <tradeName>Biossays Total Protein (Biuret)</tradeName>
    <deviceName>Total Protein (Biuret)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010230</emdnCode>
    <emdnDescription>TOTAL PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552008A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:50.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584085</udiDi>
    <basicUdiDi>69471455586X4</basicUdiDi>
    <tradeName>Biossays Direct Bilirubin (Vanadate Oxidation)</tradeName>
    <deviceName>Direct Bilirubin (Vanadate Oxidation)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552007A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:45.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584078</udiDi>
    <basicUdiDi>69471455585X2</basicUdiDi>
    <tradeName>Biossays Total Bilirubin (Vanadate Oxidation)</tradeName>
    <deviceName>Total Bilirubin (Vanadate Oxidation)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010203</emdnCode>
    <emdnDescription>BILIRUBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552006A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:43.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584061</udiDi>
    <basicUdiDi>69471455584WY</basicUdiDi>
    <tradeName>Biossays γ-Glutamyl Transferase (GCANA Substrate)</tradeName>
    <deviceName>γ-Glutamyl Transferase (GCANA Substrate)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010116</emdnCode>
    <emdnDescription>GAMMA GLUTAMYLTRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552005A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:42.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584054</udiDi>
    <basicUdiDi>69471455583WW</basicUdiDi>
    <tradeName>Biossays Alkaline Phosphatase (NPP Substrate-AMP Buffer)</tradeName>
    <deviceName>Alkaline Phosphatase (NPP Substrate-AMP Buffer)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010105</emdnCode>
    <emdnDescription>ALKALINE PHOSPHATASE - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552004A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:41.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584030</udiDi>
    <basicUdiDi>69471455581WS</basicUdiDi>
    <tradeName>Biossays Uric Acid (Uricase)</tradeName>
    <deviceName>Uric Acid (Uricase)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553002A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:35.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584047</udiDi>
    <basicUdiDi>69471455582WU</basicUdiDi>
    <tradeName>Biossays Glucose (Hexokinase)</tradeName>
    <deviceName>Glucose (Hexokinase)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010213</emdnCode>
    <emdnDescription>GLUCOSE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130555001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:34.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584023</udiDi>
    <basicUdiDi>69471455580WQ</basicUdiDi>
    <tradeName>Biossays Creatinine (Sarcosine Oxidase)</tradeName>
    <deviceName>Creatinine (Sarcosine Oxidase)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:32.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584016</udiDi>
    <basicUdiDi>69471455579X7</basicUdiDi>
    <tradeName>Biossays Aspartate Aminotransferase (Aspartic Acid Substrate)</tradeName>
    <deviceName>Aspartate Aminotransferase (Aspartic Acid Substrate)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010110</emdnCode>
    <emdnDescription>ASPARTATE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:31.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145584009</udiDi>
    <basicUdiDi>69471455578X5</basicUdiDi>
    <tradeName>Biossays Alanine Aminotransferase (Alanine Substrate)</tradeName>
    <deviceName>Alanine Aminotransferase (Alanine Substrate)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552002A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:25.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583996</udiDi>
    <basicUdiDi>69471455577X3</basicUdiDi>
    <tradeName>Biossays Total Bile Acids (Enzymatic Cycling)</tradeName>
    <deviceName>Total Bile Acids (Enzymatic Cycling)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130552001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:24.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583989</udiDi>
    <basicUdiDi>69471455576WZ</basicUdiDi>
    <tradeName>Biossays Homocysteine (Enzymatic Cycling)</tradeName>
    <deviceName>Homocysteine (Enzymatic Cycling)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010299</emdnCode>
    <emdnDescription>SUBSTRATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551007A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:23.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583972</udiDi>
    <basicUdiDi>69471455575WX</basicUdiDi>
    <tradeName>Biossays Lipoprotein (a) (Latex Immunoturbidimetric)</tradeName>
    <deviceName>Lipoprotein (a) (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010405</emdnCode>
    <emdnDescription>LIPOPROTEIN ( A )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551006A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:21.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583965</udiDi>
    <basicUdiDi>69471455574WV</basicUdiDi>
    <tradeName>Biossays Apolipoprotein E (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein E (Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551005A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:15.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583958</udiDi>
    <basicUdiDi>69471455573WT</basicUdiDi>
    <tradeName>Biossays Triglycerides (GPO-PAP)</tradeName>
    <deviceName>Triglycerides (GPO-PAP)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551004A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:14.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583941</udiDi>
    <basicUdiDi>69471455572WR</basicUdiDi>
    <tradeName>Biossays Total Cholesterol (CHOD-PAP)</tradeName>
    <deviceName>Total Cholesterol (CHOD-PAP)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551003A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:13.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583934</udiDi>
    <basicUdiDi>69471455571WP</basicUdiDi>
    <tradeName>Biossays Low Density Lipoprotein Cholesterol (Direct-Surfactant Clearance)</tradeName>
    <deviceName>Low Density Lipoprotein Cholesterol (Direct-Surfactant Clearance)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551002A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:12.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583927</udiDi>
    <basicUdiDi>69471455570WM</basicUdiDi>
    <tradeName>Biossays High Density Lipoprotein Cholesterol (Immune Inhibition Direct)</tradeName>
    <deviceName>High Density Lipoprotein Cholesterol (Immune Inhibition Direct)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130551001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:06.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583514</udiDi>
    <basicUdiDi>69471455612WC</basicUdiDi>
    <tradeName>Biossays β2-Microglobulin (Latex Immunoturbidimetric)</tradeName>
    <deviceName>β2-Microglobulin (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553007A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:03.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145583460</udiDi>
    <basicUdiDi>69471455612WC</basicUdiDi>
    <tradeName>Biossays β2-Microglobulin (Latex Immunoturbidimetric)</tradeName>
    <deviceName>β2-Microglobulin (Latex Immunoturbidimetric)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130553007S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-27T22:21:02.713Z</lastUpdated>
  </row>
</eudamedExport>