<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701440100486</udiDi>
    <basicUdiDi>370144010227</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 3543 EZ-C F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100493</udiDi>
    <basicUdiDi>370144010227</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 3543 DR-CS E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100578</udiDi>
    <basicUdiDi>370144011026</basicUdiDi>
    <tradeName>PIXIUM DYNAMIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM SURGICAL 3131S-HDI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100585</udiDi>
    <basicUdiDi>370144010329</basicUdiDi>
    <tradeName>PIXIUM DYNAMIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM SURGICAL 2121S-AU2 F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100592</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 3543 EZ-C X D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100608</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 4343 EZ-C X D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100646</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 2430 EZ-C X J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100653</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 3543 EZ-C X J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100660</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 4343 EZ-C X J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100721</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 3543 EZ-C X F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701440100738</udiDi>
    <basicUdiDi>37014401092M</basicUdiDi>
    <tradeName>PIXIUM STATIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THALES AVS FRANCE SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000012704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIXIUM PORTABLE 4343 EZ-C X F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T17:48:05.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800001610206</udiDi>
    <basicUdiDi>B-08800001610206</basicUdiDi>
    <tradeName>08800001610206</tradeName>
    <deviceName>Digital Radiographic 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>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INNOVISION-DXII</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:46.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800001610107</udiDi>
    <basicUdiDi>B-08800001610107</basicUdiDi>
    <tradeName>08800001610107</tradeName>
    <deviceName>Digital Radiographic 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>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INNOVISION-EXII</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:30:42.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953056158</udiDi>
    <basicUdiDi>08406821BUG005197E</basicUdiDi>
    <tradeName>Definium Tempo Select</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B4400UDI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:58.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953056103</udiDi>
    <basicUdiDi>08406821BUG005206X</basicUdiDi>
    <tradeName>Definium Pace Select ET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HUALUN MEDICAL SYSTEMS CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001189</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B4600UDI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:34:58.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>08606102809132</udiDi>
    <basicUdiDi>B-08606102809132</basicUdiDi>
    <tradeName>Vision V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Visaris</manufacturerName>
    <manufacturerSrn>RS-MF-000005209</manufacturerSrn>
    <authorisedRepresentativeName>VISARIS d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022682</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1834007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:05:48.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>08606102809125</udiDi>
    <basicUdiDi>B-08606102809125</basicUdiDi>
    <tradeName>Vision X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Visaris</manufacturerName>
    <manufacturerSrn>RS-MF-000005209</manufacturerSrn>
    <authorisedRepresentativeName>VISARIS d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022682</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1832010</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:05:47.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08606102809118</udiDi>
    <basicUdiDi>B-08606102809118</basicUdiDi>
    <tradeName>Vision U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Visaris</manufacturerName>
    <manufacturerSrn>RS-MF-000005209</manufacturerSrn>
    <authorisedRepresentativeName>VISARIS d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022682</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1830005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:05:47.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08606102809101</udiDi>
    <basicUdiDi>B-08606102809101</basicUdiDi>
    <tradeName>Vision C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Visaris</manufacturerName>
    <manufacturerSrn>RS-MF-000005209</manufacturerSrn>
    <authorisedRepresentativeName>VISARIS d.o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SI-AR-000022682</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1834089</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:05:46.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671072</udiDi>
    <basicUdiDi>B-08055186671072</basicUdiDi>
    <tradeName>PRIMAX International Primo-W</tradeName>
    <deviceName>Primo-W</deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94 01 000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T17:18:35.292Z</lastUpdated>
  </row>
</eudamedExport>