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<eudamedExport entity="devices">
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    <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>42623522500146</udiDi>
    <basicUdiDi>426235225HFEDM</basicUdiDi>
    <tradeName>CompactXray</tradeName>
    <deviceName>CompactXray</deviceName>
    <manufacturerName>EBA AG</manufacturerName>
    <manufacturerSrn>DE-PR-000019904</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23393</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:28:44.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262357040092</udiDi>
    <basicUdiDi>426235704OKS1000-SystemWU</basicUdiDi>
    <tradeName>OKS 1000</tradeName>
    <deviceName>OKS 1000 - Gesamtsystem</deviceName>
    <manufacturerName>Integral Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000028463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS 1000 - komplett System</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:27:05.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262357040085</udiDi>
    <basicUdiDi>426235704OKS3000-SystemYS</basicUdiDi>
    <tradeName>OKS 3000</tradeName>
    <deviceName>OKS 3000 - Gesamtsystem</deviceName>
    <manufacturerName>Integral Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000028463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0203000x</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:27:04.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262357040078</udiDi>
    <basicUdiDi>426235704OKS2000-SystemXT</basicUdiDi>
    <tradeName>OKS 2000</tradeName>
    <deviceName>OKS 2000 - Gesamtsystem</deviceName>
    <manufacturerName>Integral Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000028463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS 2000 - komplett System</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:27:03.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262425760105</udiDi>
    <basicUdiDi>42624257621408ML</basicUdiDi>
    <tradeName>OKS3000 DR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BRS-Brieden Radiologische Systemlösungen GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000005037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21408</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:52.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262425760129</udiDi>
    <basicUdiDi>42624257621404MC</basicUdiDi>
    <tradeName>OKS 1000 DR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BRS-Brieden Radiologische Systemlösungen GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000005037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110310</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:05:51.976Z</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>
  <row>
    <udiDi>08800011120085</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-C40S</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-C40S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120092</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-C52S</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-C52S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120108</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-U32S</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-U32S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800011120115</udiDi>
    <basicUdiDi>88000111ASGS20009P</basicUdiDi>
    <tradeName>GXR-U40S</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-U40S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:45.238Z</lastUpdated>
  </row>
</eudamedExport>