<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
  <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>
</eudamedExport>