<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800011170028</udiDi>
    <basicUdiDi>88000111RPSGEM6000P2</basicUdiDi>
    <tradeName>GEMPACS</tradeName>
    <deviceName>Radiological PACS Software</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEMPACS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:11.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150129</udiDi>
    <basicUdiDi>88000111DMR50002G</basicUdiDi>
    <tradeName>RAYMO</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RAYMO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:11.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150105</udiDi>
    <basicUdiDi>88000111DMP5000ZP</basicUdiDi>
    <tradeName>PROMO</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROMO</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:10.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150082</udiDi>
    <basicUdiDi>88000111AM5000UM</basicUdiDi>
    <tradeName>JADE-32</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JADE-32</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:06.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011150006</udiDi>
    <basicUdiDi>88000111DM5000VU</basicUdiDi>
    <tradeName>TOPAZ-32D</tradeName>
    <deviceName>Mobile X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOPAZ-32D</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:05.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011140038</udiDi>
    <basicUdiDi>88000111DSGSD4000PB</basicUdiDi>
    <tradeName>GXR-32SD</tradeName>
    <deviceName>Digital diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-32SD</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:04.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011140007</udiDi>
    <basicUdiDi>88000111DSDIA4000GM</basicUdiDi>
    <tradeName>DIAMOND-5A</tradeName>
    <deviceName>Digital diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIAMOND-5A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:03.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011130008</udiDi>
    <basicUdiDi>88000111DISACQ300022</basicUdiDi>
    <tradeName>ACQUIDR</tradeName>
    <deviceName>Digital Imaging System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039021</emdnCode>
    <emdnDescription>RADIOGRAPHY VIDEO ACQUISITION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACQUIDR</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:48.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011121983</udiDi>
    <basicUdiDi>88000111ASDIA2000E2</basicUdiDi>
    <tradeName>DIAMOND-5B</tradeName>
    <deviceName>Diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIAMOND-5B</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:47.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011121648</udiDi>
    <basicUdiDi>88000111ASGE20004V</basicUdiDi>
    <tradeName>GXR-E20S</tradeName>
    <deviceName>Diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-E20S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:43.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120009</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-32S</tradeName>
    <deviceName>Diagnostic X-ray System</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-32S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:42.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011104016</udiDi>
    <basicUdiDi>88000111BLD0400TM</basicUdiDi>
    <tradeName>DXC-RML</tradeName>
    <deviceName>X-ray collimator</deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039080</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXC-RML</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:15:42.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011104023</udiDi>
    <basicUdiDi>88000111BLD0400TM</basicUdiDi>
    <tradeName>DXC-RMH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039080</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXC-RMH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120016</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-32S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-32S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120023</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-40S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-40S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120030</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-40S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-40S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120047</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-52S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-52S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120054</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-68S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-68S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120061</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-82S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-82S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120078</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-C32S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRGEM Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000017990</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXR-C32S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.286Z</lastUpdated>
  </row>
</eudamedExport>