<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809244065088</udiDi>
    <basicUdiDi>880924406HESTIALR</basicUdiDi>
    <tradeName>HESTIA</tradeName>
    <deviceName>HESITA</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>507</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:35.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244065026</udiDi>
    <basicUdiDi>880924406DMX600F7</basicUdiDi>
    <tradeName>DMX-600</tradeName>
    <deviceName>DMX-600</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:33.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244065019</udiDi>
    <basicUdiDi>880924406MX600EY</basicUdiDi>
    <tradeName>MX-600</tradeName>
    <deviceName>MX-600</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030201</emdnCode>
    <emdnDescription>CONVENTIONAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:31.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060533</udiDi>
    <basicUdiDi>880924406AREXKQ</basicUdiDi>
    <tradeName>BELLIGER ACE</tradeName>
    <deviceName>BELLIGER ACE (AREX)</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:29.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060120</udiDi>
    <basicUdiDi>880924406ZEN2090QJ</basicUdiDi>
    <tradeName>ZEN-2090 Turbo</tradeName>
    <deviceName>ZEN-2090 Turbo (XENO-360)</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:28.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060106</udiDi>
    <basicUdiDi>880924406OSCARKZ</basicUdiDi>
    <tradeName>OSCAR Prime</tradeName>
    <deviceName>OSCAR (OSCAR Prime(Unique Start FD), OSCAR Classic (Unique Class))</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:27.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060069</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>OSCAR 15i</tradeName>
    <deviceName>OSCAR 15FD (Unique FD, OPESCOPE ACTENO FD15, SC15), OSCAR 15i, OSCAR 15iL</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:24.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060021</udiDi>
    <basicUdiDi>B-08809244060021</basicUdiDi>
    <tradeName>ZEN-2090Pro(ZEN-CX2090, ZEN-2090 Turbo, XENO-360)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060113</udiDi>
    <basicUdiDi>880924406OSCARKZ</basicUdiDi>
    <tradeName>OSCAR Classic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060168</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>Unique FD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060175</udiDi>
    <basicUdiDi>880924406OSCARKZ</basicUdiDi>
    <tradeName>Unique Class</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060199</udiDi>
    <basicUdiDi>B-08809244060199</basicUdiDi>
    <tradeName>PAPAYA(GDP-1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060229</udiDi>
    <basicUdiDi>B-08809244060229</basicUdiDi>
    <tradeName>PAPAYA Plus(GDP-1C, VOLUX 29)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060236</udiDi>
    <basicUdiDi>B-08809244060236</basicUdiDi>
    <tradeName>PAPAYA 3D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060243</udiDi>
    <basicUdiDi>B-08809244060243</basicUdiDi>
    <tradeName>PAPAYA 3D Plus (VOLUX 55)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060250</udiDi>
    <basicUdiDi>B-08809244060250</basicUdiDi>
    <tradeName>PAPAYA 3D Premium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060281</udiDi>
    <basicUdiDi>B-08809244060281</basicUdiDi>
    <tradeName>PAPAYA 3D Premium Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>705</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060359</udiDi>
    <basicUdiDi>880924406ZEN2090QJ</basicUdiDi>
    <tradeName>XENO-360</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060458</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>OSCAR 15FD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809244060519</udiDi>
    <basicUdiDi>880924406OSCAR15UD</basicUdiDi>
    <tradeName>OSCAR 15iL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039009</emdnCode>
    <emdnDescription>FLUOROSCOPY DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T16:53:35.157Z</lastUpdated>
  </row>
</eudamedExport>