<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-URS-11T7S</udiDi>
    <basicUdiDi>B-URS-11T7S</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>URS-11T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:24.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-10T7P</udiDi>
    <basicUdiDi>B-URS-10T7P</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</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>URS-10T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:17.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MF-000015786PROHMTW</udiDi>
    <basicUdiDi>B-KR-MF-000015786PROHMTW</basicUdiDi>
    <tradeName>HEALTHMATE Vaginal pH</tradeName>
    <deviceName>HEALTHMATE</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>3134/31I4/31H4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:37.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-MF-000015786PRODUSKP</udiDi>
    <basicUdiDi>B-KR-MF-000015786PRODUSKP</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:36.982Z</lastUpdated>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>D-73811HV</udiDi>
    <basicUdiDi>B-73811HV</basicUdiDi>
    <tradeName>AUTION Sheath Solution</tradeName>
    <deviceName>AUTION Sheath Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73811</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:22.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73810HT</udiDi>
    <basicUdiDi>B-73810HT</basicUdiDi>
    <tradeName>AUTION Staining Solution (BAC)</tradeName>
    <deviceName>AUTION Staining Solution (BAC)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73810</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:21.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73809JA</udiDi>
    <basicUdiDi>B-73809JA</basicUdiDi>
    <tradeName>AUTION Staining Solution (SED)</tradeName>
    <deviceName>AUTION Staining Solution (SED)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73809</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:20.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73808J8</udiDi>
    <basicUdiDi>B-73808J8</basicUdiDi>
    <tradeName>AUTION Diluent (BAC)</tradeName>
    <deviceName>AUTION Diluent (BAC)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73808</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:19.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73807J6</udiDi>
    <basicUdiDi>B-73807J6</basicUdiDi>
    <tradeName>AUTION Diluent (SED)</tradeName>
    <deviceName>AUTION Diluent (SED)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73807</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:15.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105582MU</udiDi>
    <basicUdiDi>B-105582MU</basicUdiDi>
    <tradeName>AUTION EYE Sheath Solution</tradeName>
    <deviceName>AUTION EYE Sheath Solution</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105582</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:30.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285183425</udiDi>
    <basicUdiDi>B-08693285183425</basicUdiDi>
    <tradeName>08693285183425</tradeName>
    <deviceName>Urinalysis Strip (10P &amp; 11P)</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTUS02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:29:50.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285183418</udiDi>
    <basicUdiDi>B-08693285183418</basicUdiDi>
    <tradeName>08693285183418</tradeName>
    <deviceName>Urinalysis Strip (10P &amp; 11P)</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTUS01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:29:49.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285181094</udiDi>
    <basicUdiDi>B-08693285181094</basicUdiDi>
    <tradeName>08693285181094</tradeName>
    <deviceName>Urinalysis Strip (10P &amp; 11P)</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUS02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:45.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>08693285181087</udiDi>
    <basicUdiDi>B-08693285181087</basicUdiDi>
    <tradeName>08693285181087</tradeName>
    <deviceName>Urinalysis Strip (10P &amp; 11P)</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUS01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:43.310Z</lastUpdated>
  </row>
</eudamedExport>