<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08054890480376</udiDi>
    <basicUdiDi>805489048PENQ7</basicUdiDi>
    <tradeName>MCP-MA</tradeName>
    <deviceName>Stativo Pensile</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030501</emdnCode>
    <emdnDescription>COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCP-MA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:22:21.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054890480161</udiDi>
    <basicUdiDi>805489048TLRRQ</basicUdiDi>
    <tradeName>WST-SX</tradeName>
    <deviceName>Wall Stand units</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030506</emdnCode>
    <emdnDescription>TELERADIOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WST-SX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:22:19.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278620453</udiDi>
    <basicUdiDi>8406821BUG00032GR</basicUdiDi>
    <tradeName>Deep Learning Image Reconstruction</tradeName>
    <deviceName>Deep Learning Image Reconstruction</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5928863</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:18:05.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278547088</udiDi>
    <basicUdiDi>8406821BUG00114GU</basicUdiDi>
    <tradeName>Liver Suite</tradeName>
    <deviceName>Liver Suite</deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5918502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:59.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278539823</udiDi>
    <basicUdiDi>8406821BUG00127H5</basicUdiDi>
    <tradeName>TrackVision 2</tradeName>
    <deviceName>Vision Applications</deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030192</emdnCode>
    <emdnDescription>DIGITAL ANGIOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5884028</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:58.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278534064</udiDi>
    <basicUdiDi>8406821BUG00201GQ</basicUdiDi>
    <tradeName>Spine Auto Views</tradeName>
    <deviceName>Spine Auto Views</deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5914361</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:57.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278502179</udiDi>
    <basicUdiDi>8406821BUG00014GP</basicUdiDi>
    <tradeName>Revolution Apex Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5590000-25</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:37.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278498649</udiDi>
    <basicUdiDi>8406821BUG00217H7</basicUdiDi>
    <tradeName>CardIQ Suite</tradeName>
    <deviceName>CardIQ Suite</deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5882923</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:33.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278494542</udiDi>
    <basicUdiDi>8406821BUG00243H8</basicUdiDi>
    <tradeName>Performix Pulsar</tradeName>
    <deviceName>Performix</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001861</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039012</emdnCode>
    <emdnDescription>X-RAY TUBE ASSEMBLY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5886600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:32.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278485144</udiDi>
    <basicUdiDi>8406821BUG00099HR</basicUdiDi>
    <tradeName>IGS 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems SCS</manufacturerName>
    <manufacturerSrn>FR-MF-000000687</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030102</emdnCode>
    <emdnDescription>STATIONARY ANGIOGRAPHY SYSTEMS FOR ANGIOGRAPHIC AND CARDIOLOGIC STUDIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5872892</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:24.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278471277</udiDi>
    <basicUdiDi>8406821BUG00154H8</basicUdiDi>
    <tradeName>Revolution CT ES with Apex edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution CT ES with Apex edition</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:19.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278469700</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Select</tradeName>
    <deviceName>Revolution Apex Select</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Power Xtream: B7919QT; Power Pro: B7919QS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:18.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278466488</udiDi>
    <basicUdiDi>8406821BUG00215H3</basicUdiDi>
    <tradeName>RT Refresh Package</tradeName>
    <deviceName>RT Refresh Package</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B79612DA, B79602DA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:13.392Z</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>08057737121487</udiDi>
    <basicUdiDi>805773712FT2519P</basicUdiDi>
    <tradeName>VDX Next System 4343VW STD</tradeName>
    <deviceName>VDX Next System</deviceName>
    <manufacturerName>Villa Sistemi Medicali S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039021</emdnCode>
    <emdnDescription>RADIOGRAPHY VIDEO ACQUISITION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8785V05000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:14:35.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671010</udiDi>
    <basicUdiDi>805518667MX/1000D9</basicUdiDi>
    <tradeName>MX/1000 FP21</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>Z11039006</emdnCode>
    <emdnDescription>RADIOLOGY CONTROL UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93 02 000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:10.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186670211</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>OMNISCOP DReam</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-1; 74 11 000-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:09.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186670150</udiDi>
    <basicUdiDi>805518667FP-SFH</basicUdiDi>
    <tradeName>FDX Visionary CS</tradeName>
    <deviceName></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>MDR 2017/745</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95 05 000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:08.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>08054890480369</udiDi>
    <basicUdiDi>805489048PENQ7</basicUdiDi>
    <tradeName>CS3101</tradeName>
    <deviceName>Stativo Pensile</deviceName>
    <manufacturerName>General Medical Merate S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023169</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030502</emdnCode>
    <emdnDescription>CEILING STANDS FOR RADIOLOGICAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS3101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:13:06.826Z</lastUpdated>
  </row>
</eudamedExport>