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<eudamedExport entity="devices">
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    <udiDi>08809394330517</udiDi>
    <basicUdiDi>B-08809394330517</basicUdiDi>
    <tradeName>VIVIX-M 2430D</tradeName>
    <deviceName>VIVIX-M 2430D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXMD-2430DAL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:14.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330500</udiDi>
    <basicUdiDi>B-08809394330500</basicUdiDi>
    <tradeName>VIVIX-M 2430D</tradeName>
    <deviceName>VIVIX-M 2430D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXMD-2430DAH</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:14.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330494</udiDi>
    <basicUdiDi>B-08809394330494</basicUdiDi>
    <tradeName>VIVIX-D</tradeName>
    <deviceName>VIVIX-D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXDD-1012CHA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:13.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330487</udiDi>
    <basicUdiDi>B-08809394330487</basicUdiDi>
    <tradeName>VIVIX-D</tradeName>
    <deviceName>VIVIX-D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXDD-1717GA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:09.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330449</udiDi>
    <basicUdiDi>B-08809394330449</basicUdiDi>
    <tradeName>VIVIX-D</tradeName>
    <deviceName>VIVIX-D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXDD-1212GA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:08.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330432</udiDi>
    <basicUdiDi>B-08809394330432</basicUdiDi>
    <tradeName>VIVIX-D</tradeName>
    <deviceName>VIVIX-D</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXDD-0909GA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:07.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330401</udiDi>
    <basicUdiDi>B-08809394330401</basicUdiDi>
    <tradeName>Slimpac II Plus</tradeName>
    <deviceName>Slimpac II Plus</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031182</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Slimpac II Plus</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:06.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330395</udiDi>
    <basicUdiDi>B-08809394330395</basicUdiDi>
    <tradeName>VXvue Mammo</tradeName>
    <deviceName>VXvue Mammo</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031182</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VXvue Mammo</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:02.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330364</udiDi>
    <basicUdiDi>B-08809394330364</basicUdiDi>
    <tradeName>VIVIX-M 2430S</tradeName>
    <deviceName>VIVIX-M 2430S</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXMD-2430S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:00.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330357</udiDi>
    <basicUdiDi>B-08809394330357</basicUdiDi>
    <tradeName>VIVIX-M 1824S</tradeName>
    <deviceName>VIVIX-M 1824S</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXMD-1008S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:59.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330272</udiDi>
    <basicUdiDi>B-08809394330272</basicUdiDi>
    <tradeName>VIVIX-S 1012N</tradeName>
    <deviceName>VIVIX-S 1012N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1012NB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:56.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330265</udiDi>
    <basicUdiDi>B-08809394330265</basicUdiDi>
    <tradeName>VIVIX-S 1012N</tradeName>
    <deviceName>VIVIX-S 1012N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1012NA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:54.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330234</udiDi>
    <basicUdiDi>B-08809394330234</basicUdiDi>
    <tradeName>VIVIX-S 1417N</tradeName>
    <deviceName>VIVIX-S 1417N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1417NBW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:54.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330227</udiDi>
    <basicUdiDi>B-08809394330227</basicUdiDi>
    <tradeName>VIVIX-S 1417N</tradeName>
    <deviceName>VIVIX-S 1417N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1417NAW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:53.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330210</udiDi>
    <basicUdiDi>B-08809394330210</basicUdiDi>
    <tradeName>VIVIX-S 1717N</tradeName>
    <deviceName>VIVIX-S 1717N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1717NBW</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:48.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330203</udiDi>
    <basicUdiDi>B-08809394330203</basicUdiDi>
    <tradeName>VIVIX-S 1717N</tradeName>
    <deviceName>VIVIX-S 1717N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1717NAW</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:47.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330197</udiDi>
    <basicUdiDi>B-08809394330197</basicUdiDi>
    <tradeName>VIVIX-S 1717N</tradeName>
    <deviceName>VIVIX-S 1717N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1717NB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:46.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330180</udiDi>
    <basicUdiDi>B-08809394330180</basicUdiDi>
    <tradeName>VIVIX-S 1717N</tradeName>
    <deviceName>VIVIX-S 1717N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1717NA</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:46.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330173</udiDi>
    <basicUdiDi>B-08809394330173</basicUdiDi>
    <tradeName>VIVIX-S 1012N</tradeName>
    <deviceName>VIVIX-S 1012N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1012NBW</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:42.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330166</udiDi>
    <basicUdiDi>B-08809394330166</basicUdiDi>
    <tradeName>VIVIX-S 1012N</tradeName>
    <deviceName>VIVIX-S 1012N</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FXRD-1012NAW</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:46:41.354Z</lastUpdated>
  </row>
</eudamedExport>