<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278688552</udiDi>
    <basicUdiDi>8406821BUG00061GY</basicUdiDi>
    <tradeName>CardEP</tradeName>
    <deviceName></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>5934726</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688569</udiDi>
    <basicUdiDi>8406821BUG00077HF</basicUdiDi>
    <tradeName>OncoQuant</tradeName>
    <deviceName></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>5934746</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688576</udiDi>
    <basicUdiDi>8406821BUG00079HK</basicUdiDi>
    <tradeName>PROView</tradeName>
    <deviceName></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>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5934749</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688583</udiDi>
    <basicUdiDi>8406821BUG00113GS</basicUdiDi>
    <tradeName>GSI Viewer</tradeName>
    <deviceName></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>5934741</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688606</udiDi>
    <basicUdiDi>8406821BUG00063H4</basicUdiDi>
    <tradeName>CardIQ Function Xpress</tradeName>
    <deviceName></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>5934728</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688613</udiDi>
    <basicUdiDi>8406821BUG00083HA</basicUdiDi>
    <tradeName>VesselIQ Xpress</tradeName>
    <deviceName></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>5934754</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688620</udiDi>
    <basicUdiDi>8406821BUG00064H6</basicUdiDi>
    <tradeName>CardIQ Fusion PET</tradeName>
    <deviceName></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>5934729</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688637</udiDi>
    <basicUdiDi>8406821BUG00078HH</basicUdiDi>
    <tradeName>PET VCAR</tradeName>
    <deviceName></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>Z11020492</emdnCode>
    <emdnDescription>POSITRON EMISSION TOMOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5934747</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688644</udiDi>
    <basicUdiDi>8406821BUG00065H8</basicUdiDi>
    <tradeName>CardIQ Xpress 2.0</tradeName>
    <deviceName></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>5934731</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688873</udiDi>
    <basicUdiDi>8406821BUG00066HA</basicUdiDi>
    <tradeName>CT Perfusion 4D</tradeName>
    <deviceName></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>5940383</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278690388</udiDi>
    <basicUdiDi>8406821BUG00189HT</basicUdiDi>
    <tradeName>00195278690388</tradeName>
    <deviceName>Versana Premier, Versana Premier Lotus</deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Versana Premier R3 VS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278690395</udiDi>
    <basicUdiDi>8406821BUG00189HT</basicUdiDi>
    <tradeName>00195278690395</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Versana Premier R3 VA/ 5938559</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278690401</udiDi>
    <basicUdiDi>8406821BUG00189HT</basicUdiDi>
    <tradeName>00195278690401</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Versana Premier Lotus 4PP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278690418</udiDi>
    <basicUdiDi>8406821BUG00189HT</basicUdiDi>
    <tradeName>00195278690418</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Versana Premier Lotus 5PP/5938561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278699800</udiDi>
    <basicUdiDi>8406821BUG00372HL</basicUdiDi>
    <tradeName>Voluson Expert 18 BT24</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Austria GmbH &amp; Co OG</manufacturerName>
    <manufacturerSrn>AT-MF-000001461</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Expert 18 BT24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278699824</udiDi>
    <basicUdiDi>8406821BUG00372HL</basicUdiDi>
    <tradeName>00195278699824</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Austria GmbH &amp; Co OG</manufacturerName>
    <manufacturerSrn>AT-MF-000001461</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Expert 20 BT24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278699848</udiDi>
    <basicUdiDi>8406821BUG00372HL</basicUdiDi>
    <tradeName>00195278699848</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Austria GmbH &amp; Co OG</manufacturerName>
    <manufacturerSrn>AT-MF-000001461</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040104</emdnCode>
    <emdnDescription>MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson Expert 22 BT24</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278703200</udiDi>
    <basicUdiDi>8406821BUG00053GZ</basicUdiDi>
    <tradeName>Venue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000016119</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue R5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278703217</udiDi>
    <basicUdiDi>8406821BUG00285HQ</basicUdiDi>
    <tradeName>Venue Fit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000016119</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Fit R5W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278703224</udiDi>
    <basicUdiDi>8406821BUG00285HQ</basicUdiDi>
    <tradeName>Venue Fit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000016119</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Fit R5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.598Z</lastUpdated>
  </row>
</eudamedExport>