<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800019200130</udiDi>
    <basicUdiDi>B-08800019200130</basicUdiDi>
    <tradeName>SXG-40R</tradeName>
    <deviceName>High Frequency X-ray Generator</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039011</emdnCode>
    <emdnDescription>HIGH VOLTAGE X-RAY GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:40.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019200123</udiDi>
    <basicUdiDi>B-08800019200123</basicUdiDi>
    <tradeName>SXG-32R</tradeName>
    <deviceName>High Frequency X-ray Generator</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039011</emdnCode>
    <emdnDescription>HIGH VOLTAGE X-RAY GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:39.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019200093</udiDi>
    <basicUdiDi>B-08800019200093</basicUdiDi>
    <tradeName>Anyview-500R</tradeName>
    <deviceName>C-Arm X-ray system</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:35.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019200079</udiDi>
    <basicUdiDi>B-08800019200079</basicUdiDi>
    <tradeName>Anyview-320S</tradeName>
    <deviceName>C-Arm X-ray system</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:35.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019200062</udiDi>
    <basicUdiDi>B-08800019200062</basicUdiDi>
    <tradeName>Anyview-240S</tradeName>
    <deviceName>C-Arm X-ray system</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:34.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019200086</udiDi>
    <basicUdiDi>B-08800019200086</basicUdiDi>
    <tradeName>Anyview-500S</tradeName>
    <deviceName>C-Arm X-ray system</deviceName>
    <manufacturerName>Ecotron Co.,Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000016249</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECO-ER-CAT-001C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:05:33.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800010330072</udiDi>
    <basicUdiDi>B-08800010330072</basicUdiDi>
    <tradeName>Mobile X-ray system</tradeName>
    <deviceName>AceMobile-510D</deviceName>
    <manufacturerName>BEMEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000013634</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AceMobile-510D</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:02.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800001611302</udiDi>
    <basicUdiDi>B-08800001611302</basicUdiDi>
    <tradeName>08800001611302</tradeName>
    <deviceName>Mobile C-Arm X-ray system</deviceName>
    <manufacturerName>DK Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000006102</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROSTAR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:46.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800001600054</udiDi>
    <basicUdiDi>B-08800001600054</basicUdiDi>
    <tradeName>08800001600054</tradeName>
    <deviceName>Portable X-ray system</deviceName>
    <manufacturerName>DK Medical Systems Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000006102</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elpo-32</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:40.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000500133</udiDi>
    <basicUdiDi>B-08800000500133</basicUdiDi>
    <tradeName>08800000500133</tradeName>
    <deviceName>Portable X-Ray system</deviceName>
    <manufacturerName>Dexcowin</manufacturerName>
    <manufacturerSrn>KR-MF-000032389</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-08</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:29.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000500065</udiDi>
    <basicUdiDi>B-08800000500065</basicUdiDi>
    <tradeName>08800000500065</tradeName>
    <deviceName>Portable dental X-ray system</deviceName>
    <manufacturerName>Dexcowin</manufacturerName>
    <manufacturerSrn>KR-MF-000032389</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-07</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:28.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000500164</udiDi>
    <basicUdiDi>B-08800000500164</basicUdiDi>
    <tradeName>08800000500164</tradeName>
    <deviceName>Portable Dental x-ray system</deviceName>
    <manufacturerName>Dexcowin</manufacturerName>
    <manufacturerSrn>KR-MF-000032389</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:27.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000500010</udiDi>
    <basicUdiDi>B-08800000500010</basicUdiDi>
    <tradeName>08800000500010</tradeName>
    <deviceName>Portable X-ray system</deviceName>
    <manufacturerName>Dexcowin</manufacturerName>
    <manufacturerSrn>KR-MF-000032389</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:10.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000500003</udiDi>
    <basicUdiDi>B-08800000500003</basicUdiDi>
    <tradeName>08800000500003</tradeName>
    <deviceName>Portable X-ray system</deviceName>
    <manufacturerName>Dexcowin</manufacturerName>
    <manufacturerSrn>KR-MF-000032389</manufacturerSrn>
    <authorisedRepresentativeName>S.B. Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005392</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-02</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:09.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770020839139</udiDi>
    <basicUdiDi>37700208390006L2</basicUdiDi>
    <tradeName>BoneCT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GLEAMER</manufacturerName>
    <manufacturerSrn>FR-MF-000011358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BoneCT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:07.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770020839078</udiDi>
    <basicUdiDi>377002083900003AJ</basicUdiDi>
    <tradeName>ChestView</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GLEAMER</manufacturerName>
    <manufacturerSrn>FR-MF-000011358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ChestView</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:01.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>B225100000150</udiDi>
    <basicUdiDi>++B225XRAYSYSTEMLH</basicUdiDi>
    <tradeName>Orthoscan TAU Mini C-Arm 1512</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ziehm-Orthoscan Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008469</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000-0015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:45:43.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>B225100000160</udiDi>
    <basicUdiDi>++B225XRAYSYSTEMLH</basicUdiDi>
    <tradeName>Orthoscan TAU Mini C-Arm 1515</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ziehm-Orthoscan Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008469</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000-0016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:45:30.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>B225100000170</udiDi>
    <basicUdiDi>++B225XRAYSYSTEMLH</basicUdiDi>
    <tradeName>Orthoscan TAU Mini C-Arm 2020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ziehm-Orthoscan Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008469</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000-0017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:44:59.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>B225100000200</udiDi>
    <basicUdiDi>++B225XRAYSYSTEMLH</basicUdiDi>
    <tradeName>Orthoscan VERSA Mini C-Arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ziehm-Orthoscan Inc</manufacturerName>
    <manufacturerSrn>US-MF-000008469</manufacturerSrn>
    <authorisedRepresentativeName>QNET B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002695</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000-0020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:44:58.936Z</lastUpdated>
  </row>
</eudamedExport>