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<eudamedExport entity="devices">
  <row>
    <udiDi>05992790341010</udiDi>
    <basicUdiDi>5992790D27HK</basicUdiDi>
    <tradeName>DiaSheath U II</tradeName>
    <deviceName>DiaSheath U II</deviceName>
    <manufacturerName>Diagon Diagnosztikai Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000023582</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>h34101</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:28:52.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562433940</udiDi>
    <basicUdiDi>4987562UF-CELLPACKCRH4</basicUdiDi>
    <tradeName>04987562433940</tradeName>
    <deviceName>UF-CELLPACK 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>CB-505-392</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:33.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562433933</udiDi>
    <basicUdiDi>4987562UF-CELLPACKSFHU</basicUdiDi>
    <tradeName>04987562433933</tradeName>
    <deviceName>UF-CELLPACK 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>CE-604-532</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:41:32.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987486035985</udiDi>
    <basicUdiDi>4987486BC0107664HF</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010902</emdnCode>
    <emdnDescription>URINE SEDIMENT TEST KIT (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107664</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:41.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967216131</udiDi>
    <basicUdiDi>B-06941967216131</basicUdiDi>
    <tradeName>06941967216131</tradeName>
    <deviceName>Urinalysis Strip  (Dry Chemistry Method)</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.01.04</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:37.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967216124</udiDi>
    <basicUdiDi>B-06941967216124</basicUdiDi>
    <tradeName>06941967216124</tradeName>
    <deviceName>Urinalysis Strip  (Dry Chemistry Method)</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010901</emdnCode>
    <emdnDescription>URINE MULTI-CONSTITUENT TEST STRIPS / CASSETTES (AUTOMATED)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.01.05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:45:33.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-UTI-2TLL</udiDi>
    <basicUdiDi>B-UTI-2TLL</basicUdiDi>
    <tradeName>Urinary Tract Infection Test Strip</tradeName>
    <deviceName>Urinary Tract Infection Test Strip</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>UTI-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:09:40.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-XXTHA</udiDi>
    <basicUdiDi>B-URS-XXTHA</basicUdiDi>
    <tradeName>Urinalysis Strips</tradeName>
    <deviceName>Urinalysis Strips</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010999</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS URINE TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-XXT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:34:04.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-9TNR</udiDi>
    <basicUdiDi>B-URS-9TNR</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-9T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:34:04.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-8TNN</udiDi>
    <basicUdiDi>B-URS-8TNN</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-8T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:34:02.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-7TNK</udiDi>
    <basicUdiDi>B-URS-7TNK</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-7T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:57.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-6TNG</udiDi>
    <basicUdiDi>B-URS-6TNG</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-6T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:56.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-5TND</udiDi>
    <basicUdiDi>B-URS-5TND</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-5T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:51.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-4TNA</udiDi>
    <basicUdiDi>B-URS-4TNA</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-4T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:49.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-3TN7</udiDi>
    <basicUdiDi>B-URS-3TN7</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-3T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:45.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-2TN4</udiDi>
    <basicUdiDi>B-URS-2TN4</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-2T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:43.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-1TMZ</udiDi>
    <basicUdiDi>B-URS-1TMZ</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-1T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:38.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-14T83</udiDi>
    <basicUdiDi>B-URS-14T83</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-14T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:32.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-13T7Y</udiDi>
    <basicUdiDi>B-URS-13T7Y</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-13T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:30.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-URS-12T7V</udiDi>
    <basicUdiDi>B-URS-12T7V</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-12T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:33:25.775Z</lastUpdated>
  </row>
</eudamedExport>