<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800031900063</udiDi>
    <basicUdiDi>88000319RAMS0JY</basicUdiDi>
    <tradeName>AUTODXTM Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1M100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:18.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800031900025</udiDi>
    <basicUdiDi>88000319RHRA2KQ</basicUdiDi>
    <tradeName>Epithod®616 Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E0M100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:17.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800031900346</udiDi>
    <basicUdiDi>B-08800031900346</basicUdiDi>
    <tradeName>AUTODXTM CRP Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1C500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T21:10:08.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800031900353</udiDi>
    <basicUdiDi>B-08800031900353</basicUdiDi>
    <tradeName>AUTODXTM U-Albumin Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1C800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T21:10:08.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800031900094</udiDi>
    <basicUdiDi>B-08800031900094</basicUdiDi>
    <tradeName>AUTODXTM HbA1c Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1C100, E1C150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:23:28.665Z</lastUpdated>
  </row>
</eudamedExport>