<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08059304340130</udiDi>
    <basicUdiDi>805930434ZENITFLOWCOMP4V</basicUdiDi>
    <tradeName>08059304340130</tradeName>
    <deviceName>ZENIT FLOW COMPACT</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:01.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059304340123</udiDi>
    <basicUdiDi>805930434SP30DS</basicUdiDi>
    <tradeName>dIFine P30</tradeName>
    <deviceName>dIFine P30</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA30SP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:00.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059304340116</udiDi>
    <basicUdiDi>805930434ZENITFLOWWY</basicUdiDi>
    <tradeName>08059304340116</tradeName>
    <deviceName>Zenit Flow</deviceName>
    <manufacturerName>Visia Lab S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000013016</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>57274</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:22:00.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056000800012</udiDi>
    <basicUdiDi>805600080nizonPLUSUC</basicUdiDi>
    <tradeName>nizonPLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HTA s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000033434</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nizonPLUS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:03:39.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032673403</udiDi>
    <basicUdiDi>76300326806732MQ</basicUdiDi>
    <tradeName>STAR CL</tradeName>
    <deviceName>STAR CL</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806732</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:46.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032672505</udiDi>
    <basicUdiDi>76300326871401N8</basicUdiDi>
    <tradeName>Microlab STAR IVD</tradeName>
    <deviceName>Microlab STAR IVD</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871401</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:46.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032671478</udiDi>
    <basicUdiDi>76300326806726MV</basicUdiDi>
    <tradeName>ampliCube</tradeName>
    <deviceName>ampliCube</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806726</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:45.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032670846</udiDi>
    <basicUdiDi>76300326871400N6</basicUdiDi>
    <tradeName>Microlab STARlet IVD</tradeName>
    <deviceName>Microlab STARlet IVD</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>871400</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:44.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032660427</udiDi>
    <basicUdiDi>76300326806711MG</basicUdiDi>
    <tradeName>Unio 96</tradeName>
    <deviceName>Unio 96</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806711</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:38.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032643383</udiDi>
    <basicUdiDi>76300326806692N5</basicUdiDi>
    <tradeName>Clinical NGS STARlet UV</tradeName>
    <deviceName>Clinical NGS STARlet UV</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806692</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:17.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032643246</udiDi>
    <basicUdiDi>76300326806691N3</basicUdiDi>
    <tradeName>Clinical NGS STARlet</tradeName>
    <deviceName>Clinical NGS STARlet</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806691</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:17.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032639645</udiDi>
    <basicUdiDi>76300326806677N9</basicUdiDi>
    <tradeName>RIDA®UNITY</tradeName>
    <deviceName>RIDA®UNITY</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806677</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:10.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032635456</udiDi>
    <basicUdiDi>76300326806160LX</basicUdiDi>
    <tradeName>AltoStar® Automation System AM16</tradeName>
    <deviceName>AltoStar® Automation System AM16</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806160</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:09.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032635357</udiDi>
    <basicUdiDi>76300326806170M2</basicUdiDi>
    <tradeName>MassSTAR</tradeName>
    <deviceName>MassSTAR</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806170</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:08.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032629127</udiDi>
    <basicUdiDi>76300326806681MY</basicUdiDi>
    <tradeName>GenoXtract fleXT</tradeName>
    <deviceName>GenoXtract fleXT</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806681</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:12:04.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032600027</udiDi>
    <basicUdiDi>76300326185082LS</basicUdiDi>
    <tradeName>Microlab STARlet IVD-R</tradeName>
    <deviceName>Microlab STARlet IVD-R</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>185082</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:10:59.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>07630032600010</udiDi>
    <basicUdiDi>76300326185080LN</basicUdiDi>
    <tradeName>Microlab STAR IVD-R</tradeName>
    <deviceName>Microlab STAR IVD-R</deviceName>
    <manufacturerName>Hamilton AG</manufacturerName>
    <manufacturerSrn>CH-MF-000013585</manufacturerSrn>
    <authorisedRepresentativeName>Johner Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011832</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>185080</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:10:58.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978331210044</udiDi>
    <basicUdiDi>697833121iLab-300UG</basicUdiDi>
    <tradeName>Fully automatic library preparation system</tradeName>
    <deviceName>Fully automatic library preparation system</deviceName>
    <manufacturerName>AMTK Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000046792</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLab-300</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:27:46.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978331210037</udiDi>
    <basicUdiDi>697833121iLab-200UB</basicUdiDi>
    <tradeName>Fully automatic library preparation system</tradeName>
    <deviceName>Fully automatic library preparation system</deviceName>
    <manufacturerName>AMTK Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000046792</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLab-200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:27:45.810Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978331210020</udiDi>
    <basicUdiDi>697833121iLab-100BBH</basicUdiDi>
    <tradeName>Fully automatic library preparation system</tradeName>
    <deviceName>Fully automatic library preparation system</deviceName>
    <manufacturerName>AMTK Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000046792</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02060199</emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iLab-100B</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:27:44.999Z</lastUpdated>
  </row>
</eudamedExport>