<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-102674MD</udiDi>
    <basicUdiDi>B-102674MD</basicUdiDi>
    <tradeName>AUTION MAX (AX-4030)</tradeName>
    <deviceName>AUTION MAX (AX-4030)</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102674</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:57:20.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100528LK</udiDi>
    <basicUdiDi>B-100528LK</basicUdiDi>
    <tradeName>AUTION MAX (AX-4060)</tradeName>
    <deviceName>AUTION MAX (AX-4060)</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100528</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:33.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100525LD</udiDi>
    <basicUdiDi>B-100525LD</basicUdiDi>
    <tradeName>AUTION MAX (AX-4060)</tradeName>
    <deviceName>AUTION MAX (AX-4060)</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100525</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:36:29.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978100260003</udiDi>
    <basicUdiDi>B-06978100260003</basicUdiDi>
    <tradeName>06978100260003</tradeName>
    <deviceName>Urine Strip</deviceName>
    <manufacturerName>Hivis Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000046009</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020101020101</emdnCode>
    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:00.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976625190003</udiDi>
    <basicUdiDi>B-06976625190003</basicUdiDi>
    <tradeName>06976625190003</tradeName>
    <deviceName>Vangenes NIPT analysis software</deviceName>
    <manufacturerName>Xiamen Vangenes Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000046896</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W020101020192</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:54:05.942Z</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>06974735361917</udiDi>
    <basicUdiDi>B-06974735361917</basicUdiDi>
    <tradeName>KEYU Automatic Urine Analysis System</tradeName>
    <deviceName>Automatic Urine Analysis System</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-3000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:26.278Z</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>06974735360002</udiDi>
    <basicUdiDi>B-06974735360002</basicUdiDi>
    <tradeName>KEYU Automatic Urine Analysis System</tradeName>
    <deviceName>Automatic Urine Analysis System</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>W020101020103</emdnCode>
    <emdnDescription>AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KU-2800</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:18.359Z</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>08906194470051</udiDi>
    <basicUdiDi>890619447LM006F9</basicUdiDi>
    <tradeName>LordsMed Urine Analyser</tradeName>
    <deviceName>Urine Analyser</deviceName>
    <manufacturerName>Lord's Mark Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000048403</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020101</emdnCode>
    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM006</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:54:04.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133010556</udiDi>
    <basicUdiDi>880613301055C3</basicUdiDi>
    <tradeName>Urochroma™</tradeName>
    <deviceName>Urochroma™</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020101020101</emdnCode>
    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR062</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:37.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800026300229</udiDi>
    <basicUdiDi>88000263PDPT10FQ</basicUdiDi>
    <tradeName>08800026300229</tradeName>
    <deviceName>Exdia PT10</deviceName>
    <manufacturerName>Precision Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000034861</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PD-PT10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:19:22.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058056684806</udiDi>
    <basicUdiDi>805805668CIS80003I1226ANV</basicUdiDi>
    <tradeName>SENTiFIT® 800 Analyzer</tradeName>
    <deviceName>SENTiFIT® 800 Analyzer</deviceName>
    <manufacturerName>SENTINEL CH. S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000012556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550802</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:53:59.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050247770022</udiDi>
    <basicUdiDi>805024777MSATE4</basicUdiDi>
    <tradeName>08050247770022</tradeName>
    <deviceName>MiniSAT</deviceName>
    <manufacturerName>H &amp; D S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000036620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSAT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:30.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050247770015</udiDi>
    <basicUdiDi>805024777FRASB9S</basicUdiDi>
    <tradeName>08050247770015</tradeName>
    <deviceName>FRAS Bravo</deviceName>
    <manufacturerName>H &amp; D S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000036620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRASB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:29.575Z</lastUpdated>
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  <row>
    <udiDi>08050247770008</udiDi>
    <basicUdiDi>805024777FRAS592</basicUdiDi>
    <tradeName>08050247770008</tradeName>
    <deviceName>FRAS5</deviceName>
    <manufacturerName>H &amp; D S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000036620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010299</emdnCode>
    <emdnDescription>LIMITED PANEL CHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFRAS5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:32:28.776Z</lastUpdated>
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</eudamedExport>