<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06935740713108</udiDi>
    <basicUdiDi>69357407ICAS000030AP</basicUdiDi>
    <tradeName>06935740713108</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:55:49.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740713092</udiDi>
    <basicUdiDi>69357407ICAS000030AP</basicUdiDi>
    <tradeName>06935740713092</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:55:47.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933289810265</udiDi>
    <basicUdiDi>B-06933289810265</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W219</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:05:51.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260208609</udiDi>
    <basicUdiDi>B-06933260208609</basicUdiDi>
    <tradeName>Cys-C Rapid Quantitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT2602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:25.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>05051700019040</udiDi>
    <basicUdiDi>5051700LK048.OPT6E</basicUdiDi>
    <tradeName>Optilite® Cystatin C Control Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NQ048.OPT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:04:16.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090038460013</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Reagent Kit for the Beckman Coulter AU Systems</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1103 / B08179</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:42.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090038460020</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1019 / A52765</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:42.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090038460051</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1100 / A52761</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:44:42.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>05204309152292</udiDi>
    <basicUdiDi>B-05204309152292</basicUdiDi>
    <tradeName>CYSTATIN C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0596</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-20T00:18:59.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>17090038460037</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Calibrator Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1051 / A52763</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T15:39:57.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090038460078</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:05:46.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090038460085</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystain C Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1026</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:05:46.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090038460092</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:05:46.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090038460108</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Calibrator Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gentian AS</manufacturerName>
    <manufacturerSrn>NO-MF-000003448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:05:46.610Z</lastUpdated>
  </row>
</eudamedExport>