<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944904017624</udiDi>
    <basicUdiDi>69449040SHYQ-BA38******QB</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:59:47.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053033688</udiDi>
    <basicUdiDi>69449040SHYQ-BA60******MU</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD 600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:08.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053033640</udiDi>
    <basicUdiDi>69449040SHYQ-BA4A******V6</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Spin640plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:01.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053026925</udiDi>
    <basicUdiDi>69449040SHYQ-BA49******RF</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA-480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:57:00.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053016216</udiDi>
    <basicUdiDi>69449040SHYQ-BA6M******4T</basicUdiDi>
    <tradeName>Chemistry Analyzer</tradeName>
    <deviceName>Chemistry Analyzer</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>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS-600M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:39.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999860094180</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>Pictus 700 Clinical chemistry analyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P700-3</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:48.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055273214963</udiDi>
    <basicUdiDi>50552732AMODENA033DB</basicUdiDi>
    <tradeName>RX modena</tradeName>
    <deviceName>RX modena</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RX9000</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:12:32.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>03610230006559</udiDi>
    <basicUdiDi>361023pentra_c40076</basicUdiDi>
    <tradeName>Pentra C400 ISE</tradeName>
    <deviceName>Pentra C400</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1280241013</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:51.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560161906864</udiDi>
    <basicUdiDi>0456016CA-800-ISEQ9</basicUdiDi>
    <tradeName>CA-800</tradeName>
    <deviceName>Clinical Chemistry Analyzer CA-800 with ISE</deviceName>
    <manufacturerName>Furuno Electric Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000026828</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA000001551</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:42:46.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156143196</udiDi>
    <basicUdiDi>8592156CCIN0052SJ</basicUdiDi>
    <tradeName>XL-640 with ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:29:16.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970133922996</udiDi>
    <basicUdiDi>697013392002FE</basicUdiDi>
    <tradeName>AILEX</tradeName>
    <deviceName>Automated Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Ailex Technology Group Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018920</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LY-MY-SH-03997</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:52:57.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592156143202</udiDi>
    <basicUdiDi>8592156CCIN0052SJ</basicUdiDi>
    <tradeName>XL-640 without ISE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INS00008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:50.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999860094197</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>P500 Clinical chemistry analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P500-1-O</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:05.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999860094203</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>P500 Clinical chemistry analyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P500-2</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:05.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999860094210</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>P500 Clinical chemistry analyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P500-2-O</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:19:05.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586006</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>FW500 Clinical Chemistry Analyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FW500-2</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586341</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>Autopak 300 Clinical Chemistry Autoanalyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APK300</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586358</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>Autopak 300 Clinical Chemistry Autoanalyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APK300i</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586419</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>P780 Clinical chemistry analyzer with ISE module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P780-1</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999883586426</udiDi>
    <basicUdiDi>5999860094PCCRQ</basicUdiDi>
    <tradeName>P780 Clinical chemistry analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diatron Medicinai Instrumentumok Laboratóriumi Diagnosztikai Fejlesztő-Gyártó Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000020416</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010106</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P780-2</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:22.100Z</lastUpdated>
  </row>
</eudamedExport>