<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00854344007542</udiDi>
    <basicUdiDi>B-00854344007542</basicUdiDi>
    <tradeName>00854344007542</tradeName>
    <deviceName>X-Ray Tube Assembly - Mammo</deviceName>
    <manufacturerName>Varex Imaging Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000028124</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-Ray Tube Assembly - Mammo</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:36.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00854344007535</udiDi>
    <basicUdiDi>B-00854344007535</basicUdiDi>
    <tradeName>00854344007535</tradeName>
    <deviceName>X-Ray Tube Assembly - CT</deviceName>
    <manufacturerName>Varex Imaging Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000028124</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-Ray Tube Assembly - CT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:35.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660006</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660006</tradeName>
    <deviceName>Rotating Anode X-ray Tube Assembly</deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:16.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682134101</udiDi>
    <basicUdiDi>8406821BUG00300GT</basicUdiDi>
    <tradeName>ARTEMIS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5505708</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:56:14.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977621410003</udiDi>
    <basicUdiDi>697762141KSXRT2</basicUdiDi>
    <tradeName>X-RAY TUBE ASSEMBLY</tradeName>
    <deviceName>X-RAY TUBE ASSEMBLY</deviceName>
    <manufacturerName>Konason (Guangdong) Medical Imaging Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045534</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS200</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:47:02.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974829930616</udiDi>
    <basicUdiDi>697482993uXT0344VA</basicUdiDi>
    <tradeName>06974829930616</tradeName>
    <deviceName>X-ray Tube Assembly</deviceName>
    <manufacturerName>Wuhan United Imaging Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030896</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78010064</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:35:14.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974829930609</udiDi>
    <basicUdiDi>697482993uXT0343V8</basicUdiDi>
    <tradeName>06974829930609</tradeName>
    <deviceName>X-ray Tube Assembly</deviceName>
    <manufacturerName>Wuhan United Imaging Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030896</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78007685</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:35:13.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974829930593</udiDi>
    <basicUdiDi>697482993uXT0236V6</basicUdiDi>
    <tradeName>06974829930593</tradeName>
    <deviceName>X-ray Tube Assembly</deviceName>
    <manufacturerName>Wuhan United Imaging Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030896</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78009125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:35:12.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974829930586</udiDi>
    <basicUdiDi>697482993UIHCT05501TP</basicUdiDi>
    <tradeName>06974829930586</tradeName>
    <deviceName>X-ray Tube Assembly</deviceName>
    <manufacturerName>Wuhan United Imaging Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030896</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78016080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:35:11.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974829930579</udiDi>
    <basicUdiDi>697482993uXT0550VF</basicUdiDi>
    <tradeName>06974829930579</tradeName>
    <deviceName>X-ray Tube Assembly</deviceName>
    <manufacturerName>Wuhan United Imaging Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030896</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>78019517</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:35:07.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660013</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660105</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660105</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660204</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660204</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660211</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660211</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660303</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660303</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660419</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660419</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660525</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660525</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:24.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660624</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660624</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:23.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660723</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660723</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:10.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809810660822</udiDi>
    <basicUdiDi>880981066LUC001KH</basicUdiDi>
    <tradeName>08809810660822</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LUCEM CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000026566</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T01:11:10.029Z</lastUpdated>
  </row>
</eudamedExport>