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<eudamedExport entity="devices">
  <row>
    <udiDi>D-14440FM</udiDi>
    <basicUdiDi>B-14440FM</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName>AUTION ELEVEN (AE-4020)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14440</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:02.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-14405FK</udiDi>
    <basicUdiDi>B-14405FK</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName>AUTION ELEVEN (AE-4020)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14405</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:08:00.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-108203MC</udiDi>
    <basicUdiDi>B-108203MC</basicUdiDi>
    <tradeName>AutionIDaten (AE-4070)</tradeName>
    <deviceName>AutionIDaten (AE-4070)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108203</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:38:14.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102678MM</udiDi>
    <basicUdiDi>B-102678MM</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102678</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:26.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102677MK</udiDi>
    <basicUdiDi>B-102677MK</basicUdiDi>
    <tradeName>PocketChem UA (PU-4010)</tradeName>
    <deviceName>PocketChem UA (PU-4010)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102677</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:24.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-102676MH</udiDi>
    <basicUdiDi>B-102676MH</basicUdiDi>
    <tradeName>AUTION ELEVEN (AE-4020)</tradeName>
    <deviceName>AUTION ELEVEN (AE-4020)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102676</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:22.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897146460029</udiDi>
    <basicUdiDi>489714646MR001JA</basicUdiDi>
    <tradeName>MR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MR INTERNATIONAL HEALTHCARE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000047634</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-115A</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:37:53.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290017272402</udiDi>
    <basicUdiDi>729001727240AT</basicUdiDi>
    <tradeName>17290017272402</tradeName>
    <deviceName>Minuteful - kidney test</deviceName>
    <manufacturerName>Healthy.io</manufacturerName>
    <manufacturerSrn>IL-MF-000023029</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MNT KDN.EN.GEN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:20:32.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975488440034</udiDi>
    <basicUdiDi>697548844UA22S3</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName>Urine Analyzer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-SA-200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:07:36.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972168355466</udiDi>
    <basicUdiDi>6972168352202A5</basicUdiDi>
    <tradeName>Semi-Automatic Urine Analyzer</tradeName>
    <deviceName>Semi-Automatic Urine Analyzer</deviceName>
    <manufacturerName>Maccura Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028087</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EHU9101004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:35:25.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740722018</udiDi>
    <basicUdiDi>69357407IUC000002WV</basicUdiDi>
    <tradeName>06935740722018</tradeName>
    <deviceName>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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:36.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934822535232</udiDi>
    <basicUdiDi>693482255700J5</basicUdiDi>
    <tradeName>06934822535232</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCU01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:59:53.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>26921756496436</udiDi>
    <basicUdiDi>6921756499990025X5</basicUdiDi>
    <tradeName>Quik-Check Expert U120 Smart Urine Analyzer</tradeName>
    <deviceName>Expert U120 Smart Urine Analyzer</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U118-101-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:25:33.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>26921756496412</udiDi>
    <basicUdiDi>6921756499990023WZ</basicUdiDi>
    <tradeName>Mission U120 Smart Urine Analyzer</tradeName>
    <deviceName>U120 Smart Urine Analyzer</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U117-101-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:25:33.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>26921756496399</udiDi>
    <basicUdiDi>6921756499990026X7</basicUdiDi>
    <tradeName>Quik-Check Expert U500 Urine Analyzer</tradeName>
    <deviceName>Expert U500 Urine Analyzer</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U213-107-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:25:17.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>26921756496351</udiDi>
    <basicUdiDi>6921756499990024X3</basicUdiDi>
    <tradeName>Mission U500 Urine Analyzer</tradeName>
    <deviceName>U500 Urine Analyzer</deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U211-101-201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:25:17.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053033824</udiDi>
    <basicUdiDi>69449040NYYQ-0103******97</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:55.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053033831</udiDi>
    <basicUdiDi>69449040NYYQ-0103******97</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-600T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:55.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895301684</udiDi>
    <basicUdiDi>6936895BS0172H</basicUdiDi>
    <tradeName>Urine Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:45.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740749336</udiDi>
    <basicUdiDi>69357407IUC000002WV</basicUdiDi>
    <tradeName>06935740749336</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 Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:05:33.973Z</lastUpdated>
  </row>
</eudamedExport>