<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>W0201020201</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>W0201020201</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>W0201020201</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>W0201020201</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>W0201020201</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>W0201020201</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>W0201020201</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>
  <row>
    <udiDi>26921756496344</udiDi>
    <basicUdiDi>6921756499990003WT</basicUdiDi>
    <tradeName>On Call MultiPro Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020205</emdnCode>
    <emdnDescription>TURBIDIMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G116-122-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:27.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>26921756496993</udiDi>
    <basicUdiDi>6921756499990021WV</basicUdiDi>
    <tradeName>FIAflex FIA Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acon Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006977</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F111-10111-201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:26.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030420041</udiDi>
    <basicUdiDi>5425030421031R6</basicUdiDi>
    <tradeName>Wash Solution 10L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41405</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030420058</udiDi>
    <basicUdiDi>5425030421024R9</basicUdiDi>
    <tradeName>Trigger Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030420065</udiDi>
    <basicUdiDi>5425030421017RC</basicUdiDi>
    <tradeName>System Liquid 5L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41404</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030421017</udiDi>
    <basicUdiDi>5425030421017RC</basicUdiDi>
    <tradeName>IDS-iSYS System Liquid (Syst. l)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-CS100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030421024</udiDi>
    <basicUdiDi>5425030421024R9</basicUdiDi>
    <tradeName>IDS-iSYS Trigger Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-CT100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425030421031</udiDi>
    <basicUdiDi>5425030421031R6</basicUdiDi>
    <tradeName>IDS-iSYS Wash Solution (Wash S)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-CW100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:52.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>80536089446126</udiDi>
    <basicUdiDi>805360894ACC0710067</basicUdiDi>
    <tradeName>Kit Accessories FW200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ACC07310D-001A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:41.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260636</udiDi>
    <basicUdiDi>4049095Z999500000MW</basicUdiDi>
    <tradeName>04049095260636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z9995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:24.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260698</udiDi>
    <basicUdiDi>4049095ZG1109CNS033</basicUdiDi>
    <tradeName>04049095260698</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ZG1109CNS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:24.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260704</udiDi>
    <basicUdiDi>4049095ZG3101CNS0ZE</basicUdiDi>
    <tradeName>04049095260704</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ZG3101CNS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260780</udiDi>
    <basicUdiDi>4049095Z999500000MW</basicUdiDi>
    <tradeName>04049095260780</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020182</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z9995</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.720Z</lastUpdated>
  </row>
</eudamedExport>