<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-02B0017YS</udiDi>
    <basicUdiDi>B-02B0017YS</basicUdiDi>
    <tradeName>D-02B0017YS</tradeName>
    <deviceName>Electrolyte（K∕ Na∕ Cl ∕Ca）Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010304</emdnCode>
    <emdnDescription>CHLORIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2Y001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:07.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0016YQ</udiDi>
    <basicUdiDi>B-02B0016YQ</basicUdiDi>
    <tradeName>D-02B0016YQ</tradeName>
    <deviceName>Urinary Microalbumin/Creatinine Reagent Kit (Fluorescence / Benedict-Behre method)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010207</emdnCode>
    <emdnDescription>CREATININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1X001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:06.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0015YN</udiDi>
    <basicUdiDi>B-02B0015YN</basicUdiDi>
    <tradeName>D-02B0015YN</tradeName>
    <deviceName>Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chromatography)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1P001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:05.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0014YL</udiDi>
    <basicUdiDi>B-02B0014YL</basicUdiDi>
    <tradeName>D-02B0014YL</tradeName>
    <deviceName>Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010202</emdnCode>
    <emdnDescription>BILE ACIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1Y001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:04.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0013YJ</udiDi>
    <basicUdiDi>B-02B0013YJ</basicUdiDi>
    <tradeName>D-02B0013YJ</tradeName>
    <deviceName>Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1G001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:00.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0012YG</udiDi>
    <basicUdiDi>B-02B0012YG</basicUdiDi>
    <tradeName>D-02B0012YG</tradeName>
    <deviceName>Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</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>1J001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:59.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0011YE</udiDi>
    <basicUdiDi>B-02B0011YE</basicUdiDi>
    <tradeName>D-02B0011YE</tradeName>
    <deviceName>Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH)</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010121</emdnCode>
    <emdnDescription>LACTATE DEHYDROGENASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1T001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:59.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0010YC</udiDi>
    <basicUdiDi>B-02B0010YC</basicUdiDi>
    <tradeName>D-02B0010YC</tradeName>
    <deviceName>C-Reactive Protein/Serum Amyloid A Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1Z001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:58.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0009YT</udiDi>
    <basicUdiDi>B-02B0009YT</basicUdiDi>
    <tradeName>D-02B0009YT</tradeName>
    <deviceName>C-Reactive Protein Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1E001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:54.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0008YR</udiDi>
    <basicUdiDi>B-02B0008YR</basicUdiDi>
    <tradeName>D-02B0008YR</tradeName>
    <deviceName>Glucose/Glycated Serum Albumin Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1U001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:53.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0006YM</udiDi>
    <basicUdiDi>B-02B0006YM</basicUdiDi>
    <tradeName>D-02B0006YM</tradeName>
    <deviceName>Prothrombin Time Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020801</emdnCode>
    <emdnDescription>PROTHROMBIN TIME RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1S001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:51.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0007YP</udiDi>
    <basicUdiDi>B-02B0007YP</basicUdiDi>
    <tradeName>D-02B0007YP</tradeName>
    <deviceName>APTT/PT/TT/FIB Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020802</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:51.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0005YK</udiDi>
    <basicUdiDi>B-02B0005YK</basicUdiDi>
    <tradeName>D-02B0005YK</tradeName>
    <deviceName>Urea/Creatinine/Uric Acid Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010204</emdnCode>
    <emdnDescription>UREA/BLOOD UREA NITROGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1N001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:34.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0004YH</udiDi>
    <basicUdiDi>B-02B0004YH</basicUdiDi>
    <tradeName>D-02B0004YH</tradeName>
    <deviceName>Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010103</emdnCode>
    <emdnDescription>ALANINE AMINO-TRANSFERASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1F001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:34.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0003YF</udiDi>
    <basicUdiDi>B-02B0003YF</basicUdiDi>
    <tradeName>D-02B0003YF</tradeName>
    <deviceName>β2-Microglobulin/Cystatin C Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039002</emdnCode>
    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:32.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-02B0001YB</udiDi>
    <basicUdiDi>B-02B0001YB</basicUdiDi>
    <tradeName>D-02B0001YB</tradeName>
    <deviceName>Glucose/Homocysteine/Uric Acid/Low Density Lipoprotein Cholesterol Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1Q001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:28:30.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0212YD</udiDi>
    <basicUdiDi>B-01B0212YD</basicUdiDi>
    <tradeName>D-01B0212YD</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4B003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:59.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0206YJ</udiDi>
    <basicUdiDi>B-01B0206YJ</basicUdiDi>
    <tradeName>D-01B0206YJ</tradeName>
    <deviceName>Uric Acid Test Strip</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1V003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:57.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0112Y8</udiDi>
    <basicUdiDi>B-01B0112Y8</basicUdiDi>
    <tradeName>D-01B0112Y8</tradeName>
    <deviceName>Blood Glucose and Uric Acid Meter</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4B002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:55.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-01B0111Y6</udiDi>
    <basicUdiDi>B-01B0111Y6</basicUdiDi>
    <tradeName>D-01B0111Y6</tradeName>
    <deviceName>Blood Glucose Test Strip</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:54.896Z</lastUpdated>
  </row>
</eudamedExport>