<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809661400035</udiDi>
    <basicUdiDi>B-08809661400035</basicUdiDi>
    <tradeName>ULTRA 1040HF</tradeName>
    <deviceName>ORANGE 1040HF, ORANGE 1040, ANYPLX 5</deviceName>
    <manufacturerName>ECORAY Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000004226</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>EUM-01</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:35:16.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800124900000</udiDi>
    <basicUdiDi>B-08800124900000</basicUdiDi>
    <tradeName>CLAROX</tradeName>
    <deviceName>CLAROX</deviceName>
    <manufacturerName>VSI Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000033769</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>VX-30</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:37.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800060100021</udiDi>
    <basicUdiDi>B-08800060100021</basicUdiDi>
    <tradeName>REMEX-K100</tradeName>
    <deviceName>Portable X-ray equipment</deviceName>
    <manufacturerName>REMEDI Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026327</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REM-IFU-T(K)100</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:58.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800060100014</udiDi>
    <basicUdiDi>B-08800060100014</basicUdiDi>
    <tradeName>08800060100014</tradeName>
    <deviceName>Portable X-ray equipment</deviceName>
    <manufacturerName>REMEDI Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026327</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REM-IFU-T(K)100_Instruction For Use</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:57.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900115</udiDi>
    <basicUdiDi>B-08800040900115</basicUdiDi>
    <tradeName>08800040900115</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:15.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900108</udiDi>
    <basicUdiDi>B-08800040900108</basicUdiDi>
    <tradeName>08800040900108</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:14.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900092</udiDi>
    <basicUdiDi>B-08800040900092</basicUdiDi>
    <tradeName>08800040900092</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:13.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900085</udiDi>
    <basicUdiDi>B-08800040900085</basicUdiDi>
    <tradeName>08800040900085</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:12.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900078</udiDi>
    <basicUdiDi>B-08800040900078</basicUdiDi>
    <tradeName>08800040900078</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:09.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900047</udiDi>
    <basicUdiDi>B-08800040900047</basicUdiDi>
    <tradeName>08800040900047</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:08.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900030</udiDi>
    <basicUdiDi>B-08800040900030</basicUdiDi>
    <tradeName>08800040900030</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:07.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040900009</udiDi>
    <basicUdiDi>B-08800040900009</basicUdiDi>
    <tradeName>08800040900009</tradeName>
    <deviceName>Diagnostic X-ray Unit</deviceName>
    <manufacturerName>POSKOM Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000037452</manufacturerSrn>
    <authorisedRepresentativeName>medical ECONET GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004983</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSK-CL-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:34:06.606Z</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>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>07350011170012</udiDi>
    <basicUdiDi>B-07350011170012</basicUdiDi>
    <tradeName>!M1</tradeName>
    <deviceName>!M1</deviceName>
    <manufacturerName>Solutions for tomorrow AB</manufacturerName>
    <manufacturerSrn>SE-MF-000027431</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>!M1</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:12:41.094Z</lastUpdated>
  </row>
</eudamedExport>