<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04252020400179</udiDi>
    <basicUdiDi>42520204CPLUSAP</basicUdiDi>
    <tradeName>CubePlus</tradeName>
    <deviceName>CubePlus</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-840-02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:14:40.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400148</udiDi>
    <basicUdiDi>42520204OP2P4</basicUdiDi>
    <tradeName>OP2</tradeName>
    <deviceName>OP2</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP2-1294-225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:15:35.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400131</udiDi>
    <basicUdiDi>42520204CPLUSAP</basicUdiDi>
    <tradeName>CubePlus</tradeName>
    <deviceName>CubePlus</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-270-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:15:34.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400124</udiDi>
    <basicUdiDi>42520204MR2NY</basicUdiDi>
    <tradeName>Microreader II</tradeName>
    <deviceName>Microreader II</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRII-968-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:15:33.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400049</udiDi>
    <basicUdiDi>42520204CUBE-SW4T</basicUdiDi>
    <tradeName>04252020400049</tradeName>
    <deviceName>Cube DataReader Software</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cube DataReader Software</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:15:32.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400025</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName>Cube Reader</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:15:31.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400032</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-755</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400063</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400070</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400087</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400094</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400100</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-156-01-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400117</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-880</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400155</udiDi>
    <basicUdiDi>42520204CPLUSAP</basicUdiDi>
    <tradeName>CubePlus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-929-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:24.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400162</udiDi>
    <basicUdiDi>42520204CPLUSAP</basicUdiDi>
    <tradeName>CubePlus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-784-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:24.938Z</lastUpdated>
  </row>
</eudamedExport>