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<eudamedExport entity="devices">
  <row>
    <udiDi>D-HU5181001NU</udiDi>
    <basicUdiDi>B-HU5181001NU</basicUdiDi>
    <tradeName>D-HU5181001NU</tradeName>
    <deviceName>Urinalysis Specific Gravity Calibrator</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HU5181001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:59:12.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73806J4</udiDi>
    <basicUdiDi>B-73806J4</basicUdiDi>
    <tradeName>AUTION Control Solution</tradeName>
    <deviceName>AUTION Control 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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>73806</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:14.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-73527HV</udiDi>
    <basicUdiDi>B-73527HV</basicUdiDi>
    <tradeName>AUTION CHECK Plus</tradeName>
    <deviceName>AUTION CHECK Plus</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73527</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:06:31.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608BURS3Q</udiDi>
    <basicUdiDi>B-47136487608BURS3Q</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Urine Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800401 S5800402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:18.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608B06P</udiDi>
    <basicUdiDi>B-47136487608B06P</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Multi-Purpose Analyzer</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S35010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:11.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-31111EY</udiDi>
    <basicUdiDi>B-31111EY</basicUdiDi>
    <tradeName>SG Calibrator Set</tradeName>
    <deviceName>SG Calibrator Set</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:17:14.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108.002.00295</udiDi>
    <basicUdiDi>B-108.002.00295</basicUdiDi>
    <tradeName>AlbuTrol High</tradeName>
    <deviceName>AlbuTrol High</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:11.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108.001.0028S</udiDi>
    <basicUdiDi>B-108.001.0028S</basicUdiDi>
    <tradeName>AlbuTrol Low</tradeName>
    <deviceName>AlbuTrol Low</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:09.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105638MW</udiDi>
    <basicUdiDi>B-105638MW</basicUdiDi>
    <tradeName>AUTION EYE Control Solution</tradeName>
    <deviceName>AUTION EYE Control 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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105638</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:51.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105639MY</udiDi>
    <basicUdiDi>B-105639MY</basicUdiDi>
    <tradeName>AUTION EYE Calibrator</tradeName>
    <deviceName>AUTION EYE Calibrator</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105639</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:47.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100672LT</udiDi>
    <basicUdiDi>B-100672LT</basicUdiDi>
    <tradeName>S.G. Calibrator H</tradeName>
    <deviceName>S.G. Calibrator H</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100672</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:35.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1-66C</udiDi>
    <basicUdiDi>B-1-66C</basicUdiDi>
    <tradeName>Calibrator solution for urine analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:32:55.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1-56A</udiDi>
    <basicUdiDi>B-1-56A</basicUdiDi>
    <tradeName>Quality control solution for urine analyzer</tradeName>
    <deviceName>Quality control solution for urine analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:32:54.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1-468</udiDi>
    <basicUdiDi>B-1-468</basicUdiDi>
    <tradeName>Quality Control Solution for Urine Analyzer</tradeName>
    <deviceName>Quality Control Solution for Urine Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:32:52.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967218968</udiDi>
    <basicUdiDi>697326286001982R</basicUdiDi>
    <tradeName>06941967218968</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.1F.01.10.04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:09.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975519630892</udiDi>
    <basicUdiDi>B-06975519630892</basicUdiDi>
    <tradeName>Urine Control Solution</tradeName>
    <deviceName>Urine Control Solution</deviceName>
    <manufacturerName>Hangzhou Bosure Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003001</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-101-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:08.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806125620947</udiDi>
    <basicUdiDi>88061256U513NC</basicUdiDi>
    <tradeName>URiTROL™ Liquid Level 1, 2</tradeName>
    <deviceName>URiTROL™ Liquid</deviceName>
    <manufacturerName>YD Diagnostics CORP.</manufacturerName>
    <manufacturerSrn>KR-MF-000023981</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U5-13</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:26.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740751735</udiDi>
    <basicUdiDi>69357407IUCS000008R2</basicUdiDi>
    <tradeName>Quality Control Solution for Urine Analyzer</tradeName>
    <deviceName>Quality Control Solution for Urine Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUD00000285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:36.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740750226</udiDi>
    <basicUdiDi>69357407IUCS000006QW</basicUdiDi>
    <tradeName>Calibrator Solution for Urine Analyzer</tradeName>
    <deviceName>Calibrator Solution for Urine Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUC00001088</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:36.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740750172</udiDi>
    <basicUdiDi>69357407IUCS000005QU</basicUdiDi>
    <tradeName>Quality Control Solution for Urine Analyzer</tradeName>
    <deviceName>Quality Control Solution for Urine Analyzer</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUC00001102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:34.586Z</lastUpdated>
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</eudamedExport>