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<eudamedExport entity="devices">
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    <udiDi>00816426020771</udiDi>
    <basicUdiDi>B-00816426020771</basicUdiDi>
    <tradeName>K-ASSAY Cystatin C Calibrator</tradeName>
    <deviceName>Cystatin C Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-099C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:58.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020320</udiDi>
    <basicUdiDi>B-00816426020320</basicUdiDi>
    <tradeName>K-ASSAY Cystatin C</tradeName>
    <deviceName>Cystatin C Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-074</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:21.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090038460061</udiDi>
    <basicUdiDi>9003846B01CYSC001QC</basicUdiDi>
    <tradeName>Gentian Cystatin C Reagent Kit</tradeName>
    <deviceName>Gentian Cystatin C Reagent Kit</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>1101</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:42:53.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975182500218</udiDi>
    <basicUdiDi>697518250P110015C</basicUdiDi>
    <tradeName>Cystatin C Determination Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Cystatin C Determination Kit (Fluorescence Immunochromatographic Assay)</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P11001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:20:02.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740713085</udiDi>
    <basicUdiDi>69357407ICAS000030AP</basicUdiDi>
    <tradeName>06935740713085</tradeName>
    <deviceName>Cystatin C Test Kit (Immunoturbidimetric Assay)</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>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:20.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414792676</udiDi>
    <basicUdiDi>695441470210GR</basicUdiDi>
    <tradeName>CysC Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>CysC Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF5008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:31:10.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954414702101</udiDi>
    <basicUdiDi>B-06954414702101</basicUdiDi>
    <tradeName>CysC Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>CysC Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:25:36.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802967</udiDi>
    <basicUdiDi>B-06952804802967</basicUdiDi>
    <tradeName>Cystatin C FIA</tradeName>
    <deviceName>Cystatin C FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYSC-W23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:42.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334819769</udiDi>
    <basicUdiDi>B-06950334819769</basicUdiDi>
    <tradeName>Cystatin C (CYS-C) Detection Kit (Nephelometry)</tradeName>
    <deviceName>Cystatin C (CYS-C) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32027209</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:43:01.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334804390</udiDi>
    <basicUdiDi>B-06950334804390</basicUdiDi>
    <tradeName>06950334804390</tradeName>
    <deviceName>Cystatin C (CYS-C) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32026003</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:40:06.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950334802259</udiDi>
    <basicUdiDi>B-06950334802259</basicUdiDi>
    <tradeName>06950334802259</tradeName>
    <deviceName>Cystatin C (CYS-C) Detection Kit (Nephelometry)</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32080003</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:37:27.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967201854</udiDi>
    <basicUdiDi>B-06941967201854</basicUdiDi>
    <tradeName>06941967201854</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.01.03.EC.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:46:58.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937287300452</udiDi>
    <basicUdiDi>B-06937287300452</basicUdiDi>
    <tradeName>06937287300452</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×30 mL, R2: 1×15 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:52:10.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750379</udiDi>
    <basicUdiDi>B-06936595750379</basicUdiDi>
    <tradeName>Cystatin C Kit (Latex-Enhanced Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019008</emdnCode>
    <emdnDescription>CYSTATIN C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ419Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:54:17.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740739351</udiDi>
    <basicUdiDi>69357407ICAS000030AP</basicUdiDi>
    <tradeName>06935740739351</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>2026-06-24T12:04:27.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740733342</udiDi>
    <basicUdiDi>69357407ICAS000030AP</basicUdiDi>
    <tradeName>06935740733342</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>2026-06-24T12:03:00.262Z</lastUpdated>
  </row>
  <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>
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  <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>
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