<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-7-16Y</udiDi>
    <basicUdiDi>B-7-16Y</basicUdiDi>
    <tradeName>LaserVision Urine Sediment Analyzer</tradeName>
    <deviceName>LaserVision Urine Sediment 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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:21.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-106026LY</udiDi>
    <basicUdiDi>B-106026LY</basicUdiDi>
    <tradeName>AUTION EYE (AI-4510)</tradeName>
    <deviceName>AUTION EYE (AI-4510)</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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106026</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:13.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735362242</udiDi>
    <basicUdiDi>B-06974735362242</basicUdiDi>
    <tradeName>KEYU Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-600A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:45.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735362235</udiDi>
    <basicUdiDi>B-06974735362235</basicUdiDi>
    <tradeName>KEYU Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-2000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:41.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735362228</udiDi>
    <basicUdiDi>B-06974735362228</basicUdiDi>
    <tradeName>KEYU Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UM-30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:40.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735362211</udiDi>
    <basicUdiDi>B-06974735362211</basicUdiDi>
    <tradeName>KEYU All-in-One Analyzer</tradeName>
    <deviceName>All-in-One Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fusion Scan™ FU30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:39.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974735360033</udiDi>
    <basicUdiDi>B-06974735360033</basicUdiDi>
    <tradeName>KEYU Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment Analyzer</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-600</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:19.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780227</udiDi>
    <basicUdiDi>697850778USE10WS</basicUdiDi>
    <tradeName>Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment Analyzer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN0129</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:34.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975488440577</udiDi>
    <basicUdiDi>697548844USA22VP</basicUdiDi>
    <tradeName>Urine Sediment Analyzer</tradeName>
    <deviceName>Urine Sediment 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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Evo-S50</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:08:25.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740735360</udiDi>
    <basicUdiDi>69357407IUD000002XE</basicUdiDi>
    <tradeName>06935740735360</tradeName>
    <deviceName>LaserVision Urine Sediment 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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:24.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740723435</udiDi>
    <basicUdiDi>69357407IUS0000017E</basicUdiDi>
    <tradeName>06935740723435</tradeName>
    <deviceName>AI-Libre Urinalysis System</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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:00.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740718943</udiDi>
    <basicUdiDi>69357407IUD000001XC</basicUdiDi>
    <tradeName>06935740718943</tradeName>
    <deviceName>Auto Urine Sediment 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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:03:35.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740735353</udiDi>
    <basicUdiDi>69357407IUD000001XC</basicUdiDi>
    <tradeName>06935740735353</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:57.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740732086</udiDi>
    <basicUdiDi>69357407IUS0000017E</basicUdiDi>
    <tradeName>06935740732086</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:02:29.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740725279</udiDi>
    <basicUdiDi>69357407IUS0000017E</basicUdiDi>
    <tradeName>06935740725279</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:59:55.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740723404</udiDi>
    <basicUdiDi>69357407IUD000001XC</basicUdiDi>
    <tradeName>06935740723404</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:59:20.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740723398</udiDi>
    <basicUdiDi>69357407IUD000001XC</basicUdiDi>
    <tradeName>06935740723398</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:59:19.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975488440584</udiDi>
    <basicUdiDi>697548844USA22VP</basicUdiDi>
    <tradeName>Fully Automatic Urine Sediment Analyzer</tradeName>
    <deviceName></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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UA-S3-120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:29:57.585Z</lastUpdated>
  </row>
</eudamedExport>