<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974410142084</udiDi>
    <basicUdiDi>B-06974410142084</basicUdiDi>
    <tradeName>06974410142084</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-11F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:47.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974410142053</udiDi>
    <basicUdiDi>B-06974410142053</basicUdiDi>
    <tradeName>06974410142053</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-12H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:30.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974410142039</udiDi>
    <basicUdiDi>B-06974410142039</basicUdiDi>
    <tradeName>06974410142039</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-12F</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:29.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974410142022</udiDi>
    <basicUdiDi>B-06974410142022</basicUdiDi>
    <tradeName>06974410142022</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-10F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:29.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974410142015</udiDi>
    <basicUdiDi>B-06974410142015</basicUdiDi>
    <tradeName>06974410142015</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-10H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:28.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806141303275</udiDi>
    <basicUdiDi>88061413US33D0JN</basicUdiDi>
    <tradeName>DUS 7</tradeName>
    <deviceName>Dus Series</deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3784</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:42:53.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806141302698</udiDi>
    <basicUdiDi>88061413US32D0JH</basicUdiDi>
    <tradeName>ComboStik 3</tradeName>
    <deviceName>ComboStik Series</deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:41.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806141302223</udiDi>
    <basicUdiDi>88061413US31D0JC</basicUdiDi>
    <tradeName>08806141302223</tradeName>
    <deviceName>CYBOW Series</deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4C14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:40.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142250403</udiDi>
    <basicUdiDi>859514221823082</basicUdiDi>
    <tradeName>KOWACZ ROZTOK</tradeName>
    <deviceName>KOWACZ ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18230-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:19.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142235011</udiDi>
    <basicUdiDi>859514221377084</basicUdiDi>
    <tradeName>FEHLING II ROZTOK</tradeName>
    <deviceName>FEHLING II ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13770-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:50.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142234915</udiDi>
    <basicUdiDi>85951422137607Z</basicUdiDi>
    <tradeName>FEHLING I ROZTOK</tradeName>
    <deviceName>FEHLING I ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13760-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:49.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142233116</udiDi>
    <basicUdiDi>859514221343079</basicUdiDi>
    <tradeName>EHRLICH-UROBILINOGEN ROZTOK</tradeName>
    <deviceName>EHRLICH-UROBILINOGEN ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13430-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:24.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967217626</udiDi>
    <basicUdiDi>69732628600045ZU</basicUdiDi>
    <tradeName>06941967217626</tradeName>
    <deviceName>Wash Solution</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.13.11</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:40.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967217619</udiDi>
    <basicUdiDi>69732628600044ZS</basicUdiDi>
    <tradeName>06941967217619</tradeName>
    <deviceName>Cleanser</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.13.23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:39.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967217596</udiDi>
    <basicUdiDi>69732628600043ZQ</basicUdiDi>
    <tradeName>06941967217596</tradeName>
    <deviceName>Urinalysis Diluent</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.12.05</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:38.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967217572</udiDi>
    <basicUdiDi>69732628600042ZN</basicUdiDi>
    <tradeName>06941967217572</tradeName>
    <deviceName>Sheath Fluid</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.11.12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:37.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509062</udiDi>
    <basicUdiDi>4987562UF-FluorocellSFMC</basicUdiDi>
    <tradeName>UF- Fluorocell SF</tradeName>
    <deviceName>UF- Fluorocell SF</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AV083519</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:13:00.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>14987562509055</udiDi>
    <basicUdiDi>4987562UF-FluorocellCRLL</basicUdiDi>
    <tradeName>UF- Fluorocell CR</tradeName>
    <deviceName>UF- Fluorocell CR</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BW056982</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:12:56.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806141304463</udiDi>
    <basicUdiDi>88061413US31D0JC</basicUdiDi>
    <tradeName>CYBOW 12AC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4B04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:59.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806141304470</udiDi>
    <basicUdiDi>88061413US31D0JC</basicUdiDi>
    <tradeName>CYBOW 11</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0A94</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:19:59.858Z</lastUpdated>
  </row>
</eudamedExport>