<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>16974410140032</udiDi>
    <basicUdiDi>697441014UA000162</basicUdiDi>
    <tradeName>16974410140032</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BW-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:14:46.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974410140049</udiDi>
    <basicUdiDi>697441014UA000162</basicUdiDi>
    <tradeName>16974410140049</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BW-901</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:14:46.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974410140063</udiDi>
    <basicUdiDi>697441014US0018CR</basicUdiDi>
    <tradeName>16974410140063</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BW-2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:14:46.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974410140070</udiDi>
    <basicUdiDi>697441014US0018CR</basicUdiDi>
    <tradeName>16974410140070</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BW-3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T09:14:46.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360538</udiDi>
    <basicUdiDi>697473536KUC01PE</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Cleaning Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-C-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360545</udiDi>
    <basicUdiDi>697473536KUC02PG</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Diluent Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-D02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360552</udiDi>
    <basicUdiDi>697473536KUC02PG</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Diluent Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-D03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360569</udiDi>
    <basicUdiDi>697473536KUC03PJ</basicUdiDi>
    <tradeName>KEYU Maintenance Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-M02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:45.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360705</udiDi>
    <basicUdiDi>697473536KUC02PG</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Diluent Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-D04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:44.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360712</udiDi>
    <basicUdiDi>697473536KUC03PJ</basicUdiDi>
    <tradeName>KEYU Maintenance Solution</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-M03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:44.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361405</udiDi>
    <basicUdiDi>697473536KUC17PV</basicUdiDi>
    <tradeName>KEYU Diluent Solution C</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>W02010785</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-D02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:51:43.751Z</lastUpdated>
  </row>
</eudamedExport>