<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278473097</udiDi>
    <basicUdiDi>8406821BUG00210GR</basicUdiDi>
    <tradeName>00195278473097</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson P6 BT22 / 5882279</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:02.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278473103</udiDi>
    <basicUdiDi>8406821BUG00210GR</basicUdiDi>
    <tradeName>00195278473103</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Voluson P8 BT22 / 5882489</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:02.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278503411</udiDi>
    <basicUdiDi>8406821BUG00287HU</basicUdiDi>
    <tradeName>00195278503411</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5887882</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278504326</udiDi>
    <basicUdiDi>8406821BUG00256HH</basicUdiDi>
    <tradeName>EchoPAC Plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040192</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EchoPAC Plug-in v206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.890Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278505187</udiDi>
    <basicUdiDi>8406821BUG00252H9</basicUdiDi>
    <tradeName>Vivid S60N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid S60N v206CH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278505255</udiDi>
    <basicUdiDi>8406821BUG00252H9</basicUdiDi>
    <tradeName>Vivid S70N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid S70N v206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278505316</udiDi>
    <basicUdiDi>8406821BUG00252H9</basicUdiDi>
    <tradeName>Vivid S60N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid S60N v206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278505347</udiDi>
    <basicUdiDi>8406821BUG00253HB</basicUdiDi>
    <tradeName>Vivid E80</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid E80 v206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.599Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278505354</udiDi>
    <basicUdiDi>8406821BUG00253HB</basicUdiDi>
    <tradeName>Vivid E90</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid E90 v206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516312</udiDi>
    <basicUdiDi>8406821BUG00252H9</basicUdiDi>
    <tradeName>00195278516312</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid S v203 v204 v205 to v206 UPG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516343</udiDi>
    <basicUdiDi>8406821BUG00253HB</basicUdiDi>
    <tradeName>00195278516343</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid E v203 v204 to v206 UPG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516497</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Fit R4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516503</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Fit R4W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516527</udiDi>
    <basicUdiDi>8406821BUG00284HN</basicUdiDi>
    <tradeName>Venue Go</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Go R4W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516534</udiDi>
    <basicUdiDi>8406821BUG00053GZ</basicUdiDi>
    <tradeName>Venue R4 UPG</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue R4 UPG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:01.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278516541</udiDi>
    <basicUdiDi>8406821BUG00284HN</basicUdiDi>
    <tradeName>Venue Go R4 UPG</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>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Venue Go R4 UPG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:00.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278530981</udiDi>
    <basicUdiDi>8406821BUG00254HD</basicUdiDi>
    <tradeName>00195278530981</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>UNKNOWN</legislation>
    <emdnCode>Z11040102</emdnCode>
    <emdnDescription>CARDIOLOGY ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Vivid iq v203 to v206 UPG/5904516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:00.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278560148</udiDi>
    <basicUdiDi>8406821BUG00293HP</basicUdiDi>
    <tradeName>Voluson SWIFT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040192</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H43222LS / H43222LR / H43222LN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:00.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278560155</udiDi>
    <basicUdiDi>8406821BUG00293HP</basicUdiDi>
    <tradeName>Voluson SWIFT+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040192</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H43222LR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:58:00.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278627049</udiDi>
    <basicUdiDi>8406821BUG00033GT</basicUdiDi>
    <tradeName>00195278627049</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Ultrasound Korea, Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000001860</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOGIQ E10s R3 to R4 UPG / 5874847-34</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T04:57:59.684Z</lastUpdated>
  </row>
</eudamedExport>