<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971022541014</udiDi>
    <basicUdiDi>6971022SUNVOU02425</basicUdiDi>
    <tradeName>06971022541014</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sunvou Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004543</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sunvou-HD1101 (300 times)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:55:29.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730221</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>06973602730221</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE5078AAS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730511</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>Adhesive Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB1520226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730528</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>Adhesive electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB1520124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730535</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>Adhesive electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB1010122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730542</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>Adhesive Electrodes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC2M20221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730559</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>Adhesive and conductive electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0065.043-200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730597</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>06973602730597</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Myotrode5050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730603</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>06973602730603</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Myotrode5090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730870</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>无</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>无</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973602730887</udiDi>
    <basicUdiDi>697360273ELECTRODESHX</basicUdiDi>
    <tradeName>CM5050ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP-RANK Health Care Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014102</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0101070299</emdnCode>
    <emdnDescription>SUBSTRATE - ELECTRODES / BIOSENSORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>无</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:19:31.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360316</udiDi>
    <basicUdiDi>697473536KUC11PH</basicUdiDi>
    <tradeName>KEYU Feces Analyzer Diluent Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02-C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360576</udiDi>
    <basicUdiDi>697473536KUC05PN</basicUdiDi>
    <tradeName>KEYU Sample Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-R02-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360583</udiDi>
    <basicUdiDi>697473536KUC05PN</basicUdiDi>
    <tradeName>KEYU Sample Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-R02-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360590</udiDi>
    <basicUdiDi>697473536KUC05PN</basicUdiDi>
    <tradeName>KEYU Sample Diluent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-R02-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:44.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361283</udiDi>
    <basicUdiDi>697473536KUC11PH</basicUdiDi>
    <tradeName>KEYU Feces Analyzer Diluent Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R02-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:43.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978556700047</udiDi>
    <basicUdiDi>697855670B001KL</basicUdiDi>
    <tradeName>06978556700047</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianjin Readybio Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047939</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070399</emdnCode>
    <emdnDescription>REFERENCE MATERIALS AND BUFFERS (ELECTROLYTES) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13*100mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:37:43.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962410</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. REFERENCE CONC.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962441</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. REFERENCE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>947E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033622962458</udiDi>
    <basicUdiDi>803362296240AZ</basicUdiDi>
    <tradeName>I.S.E. SOLUZIONE RIFERIMENTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biotecnica Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000008115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101070304</emdnCode>
    <emdnDescription>COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>948</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:04:25.805Z</lastUpdated>
  </row>
</eudamedExport>