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<eudamedExport entity="devices">
  <row>
    <udiDi>D-KR-MF-000015786PROCYU7</udiDi>
    <basicUdiDi>B-KR-MF-000015786PROCYU7</basicUdiDi>
    <tradeName>CYBOW 12AC</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4B04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:36.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MF-000015786PROCSTT</udiDi>
    <basicUdiDi>B-KR-MF-000015786PROCSTT</basicUdiDi>
    <tradeName>ComboStik 13</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2C04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:35.373Z</lastUpdated>
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  <row>
    <udiDi>D-KR-MF-000015786DUSelfPN</udiDi>
    <basicUdiDi>B-KR-MF-000015786DUSelfPN</basicUdiDi>
    <tradeName>DUS 12AC</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8B04/8B14/8A24/8034/8044/8854/8364/8174/8184/8194/81A4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:28.969Z</lastUpdated>
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  <row>
    <udiDi>D-KR-MF-000015786CYSelfQM</udiDi>
    <basicUdiDi>B-KR-MF-000015786CYSelfQM</basicUdiDi>
    <tradeName>UriDoctor 11</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1AN4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:24.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MF-000015786CSSelfNK</udiDi>
    <basicUdiDi>B-KR-MF-000015786CSSelfNK</basicUdiDi>
    <tradeName>ComboStik 11</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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1964 / 1AD8/1AZ4/10Y4/15F4/15P1/14I0P/14X0P/12E8/1348/1204/1314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:24.185Z</lastUpdated>
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  <row>
    <udiDi>D-IDIRMG</udiDi>
    <basicUdiDi>B-IDIRMG</basicUdiDi>
    <tradeName>IDIR</tradeName>
    <deviceName>IDIR</deviceName>
    <manufacturerName>SKILLCELL</manufacturerName>
    <manufacturerSrn>FR-MF-000024570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SKC-PDT-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:05:27.423Z</lastUpdated>
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  <row>
    <udiDi>06979359840008</udiDi>
    <basicUdiDi>B-06979359840008</basicUdiDi>
    <tradeName>06979359840008</tradeName>
    <deviceName>Urea-[13C]Breath Test Kit</deviceName>
    <manufacturerName>JiangSu ETest Medical Electronic Technology Co Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050551</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETest4100-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:39:29.400Z</lastUpdated>
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  <row>
    <udiDi>06975808410198</udiDi>
    <basicUdiDi>B-06975808410198</basicUdiDi>
    <tradeName>06975808410198</tradeName>
    <deviceName>Creatinine, Microalbumin in Urine Assay kit (Dry Chemical Method)</deviceName>
    <manufacturerName>Beijing Zhongsheng Jinyu Diagnostic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044320</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:11:56.590Z</lastUpdated>
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  <row>
    <udiDi>06974735361351</udiDi>
    <basicUdiDi>B-06974735361351</basicUdiDi>
    <tradeName>KEYU Dry Chemistry Strip</tradeName>
    <deviceName>Dry Chemistry Strip</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-14</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:34:34.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735361344</udiDi>
    <basicUdiDi>B-06974735361344</basicUdiDi>
    <tradeName>KEYU Dry Chemistry Strip</tradeName>
    <deviceName>Dry Chemistry Strip</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:34:32.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360330</udiDi>
    <basicUdiDi>B-06974735360330</basicUdiDi>
    <tradeName>KEYU Urine Reagent Strips</tradeName>
    <deviceName>Urine Reagent Strips</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-14A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:37.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360323</udiDi>
    <basicUdiDi>B-06974735360323</basicUdiDi>
    <tradeName>KEYU Urine Reagent Strips</tradeName>
    <deviceName>Urine Reagent Strips</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-12B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:35.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974541565509</udiDi>
    <basicUdiDi>B-06974541565509</basicUdiDi>
    <tradeName>06974541565509</tradeName>
    <deviceName>Urinary Tract Infection (UTI) &amp;DR Panel (Fluorescence PCR method)</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PR2024-UT01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:50:32.840Z</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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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    <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>
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</eudamedExport>