<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278577092</udiDi>
    <basicUdiDi>B-00195278577092</basicUdiDi>
    <tradeName>00195278577092</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>MDD</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5463900PCM</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-01T00:42:42.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904139700249</udiDi>
    <basicUdiDi>89041397HFX-RAYVA</basicUdiDi>
    <tradeName>Allengers</tradeName>
    <deviceName>HF X-Ray Machine (Radiography, Radiography/Fluoroscopy, Digital Radiography)</deviceName>
    <manufacturerName>Allengers Medical Systems Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000032921</manufacturerSrn>
    <authorisedRepresentativeName>Easy Medical Device</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000011902</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>AMSL/UM/MARS 80/XX/49</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:13:41.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278526892</udiDi>
    <basicUdiDi>8406821BUG00327HF</basicUdiDi>
    <tradeName>Definium Pace 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>B2604CAB</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:27:18.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278118356</udiDi>
    <basicUdiDi>8406821BUG00192HG</basicUdiDi>
    <tradeName>Definium Tempo</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</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>B2401CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:11.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278070265</udiDi>
    <basicUdiDi>8406821BUG00193HJ</basicUdiDi>
    <tradeName>Definium Tempo Pro</tradeName>
    <deviceName>Medical Diagnostic Radiology Device</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>B2402CAB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:11.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975006957501</udiDi>
    <basicUdiDi>697500695US001KF</basicUdiDi>
    <tradeName>US980</tradeName>
    <deviceName>Dental Digital Imaging Sensor</deviceName>
    <manufacturerName>Ningbo Youjoy Dental Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040566</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:43:33.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972764130252</udiDi>
    <basicUdiDi>697276413AG001BF</basicUdiDi>
    <tradeName>06972764130252</tradeName>
    <deviceName>Digital Medical X-ray Radiographic System</deviceName>
    <manufacturerName>Shenzhen Angell Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023030</manufacturerSrn>
    <authorisedRepresentativeName>Angell Technology GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000037290</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>DTP580B-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:32:06.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053089968</udiDi>
    <basicUdiDi>69449040AB050100505U</basicUdiDi>
    <tradeName>06903053089968</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>DigiEye U9 Unix</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:52:04.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053038645</udiDi>
    <basicUdiDi>69449040AB0601000466</basicUdiDi>
    <tradeName>06903053038645</tradeName>
    <deviceName>Digital Radiography System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>DigiEye 330E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:49:06.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06903053011938</udiDi>
    <basicUdiDi>69449040AB060100015Y</basicUdiDi>
    <tradeName>06903053011938</tradeName>
    <deviceName>Mobile Radiography System</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>MobiEye 750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:47:13.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999574570109</udiDi>
    <basicUdiDi>599957457DRE2F</basicUdiDi>
    <tradeName>TOP-X DR TSM</tradeName>
    <deviceName>TOP-X DR TSM</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-PR-000019069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>263-R-8104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:08.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999574570093</udiDi>
    <basicUdiDi>599957457DRD2D</basicUdiDi>
    <tradeName>TOP-X DR CHEST</tradeName>
    <deviceName>TOP-X DR CHEST</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-PR-000019069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>257-R-6669</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:07.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999574570086</udiDi>
    <basicUdiDi>599957457DRC2B</basicUdiDi>
    <tradeName>TOP-X DR-S</tradeName>
    <deviceName>TOP-X DR-S</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-PR-000019069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>261-R-9153</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:07.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999574570079</udiDi>
    <basicUdiDi>599957457DRB29</basicUdiDi>
    <tradeName>TOP-X DR TRAUMA</tradeName>
    <deviceName>TOP-X DR TRAUMA</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-PR-000019069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>255-R-6215</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:06.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999574570062</udiDi>
    <basicUdiDi>599957457DRA27</basicUdiDi>
    <tradeName>TOP-X 100 DR Classic</tradeName>
    <deviceName>TOP-X DR CLASSIC</deviceName>
    <manufacturerName>Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-PR-000019069</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11031101</emdnCode>
    <emdnDescription>MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>256-R-6668</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:40:02.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414904231975</udiDi>
    <basicUdiDi>5414904272855YW</basicUdiDi>
    <tradeName>DR 100e</tradeName>
    <deviceName>DR 100e 6012</deviceName>
    <manufacturerName>Agfa NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000571</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>XBVBO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:00:34.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414904217870</udiDi>
    <basicUdiDi>5414904272848YZ</basicUdiDi>
    <tradeName>DR 400</tradeName>
    <deviceName>DR 400 5520</deviceName>
    <manufacturerName>Agfa NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000571</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>58UCJ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:00:33.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414904275535</udiDi>
    <basicUdiDi>5414904278413Z4</basicUdiDi>
    <tradeName>Valory</tradeName>
    <deviceName>Valory 5540</deviceName>
    <manufacturerName>Agfa NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000571</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MAVV8</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:13.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414904274330</udiDi>
    <basicUdiDi>5414904272831YG</basicUdiDi>
    <tradeName>DR 600</tradeName>
    <deviceName>DR 600 5530</deviceName>
    <manufacturerName>Agfa NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000571</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MARDQ</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:12.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>05414904271032</udiDi>
    <basicUdiDi>5414904272787Z6</basicUdiDi>
    <tradeName>DR 100s</tradeName>
    <deviceName>DR 100s 6013</deviceName>
    <manufacturerName>Agfa NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000571</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MAC3H</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:53:08.037Z</lastUpdated>
  </row>
</eudamedExport>