<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00840682104487</udiDi>
    <basicUdiDi>8406821BUG00364HM</basicUdiDi>
    <tradeName>3.0T HD 8CH CTL ARRAY</tradeName>
    <deviceName>3.0T HD 8Ch CTL Array</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2415542</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:54:08.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682103893</udiDi>
    <basicUdiDi>8406821BUG00390HN</basicUdiDi>
    <tradeName>Panda iRes Warmer</tradeName>
    <deviceName>Panda iRes Warmer</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1112198</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:55.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682103756</udiDi>
    <basicUdiDi>8406821BUG00359HU</basicUdiDi>
    <tradeName>3.0T HD BREAST ARRAY</tradeName>
    <deviceName>1.5T and 3.0T HD Breast Arrays</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2415544</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:54.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682103732</udiDi>
    <basicUdiDi>8406821BUG00362HH</basicUdiDi>
    <tradeName>3.0T HD SHOULDER ARRAY</tradeName>
    <deviceName>1.5T and 3.0T HD Shoulder Arrays</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2414331</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:52.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682102483</udiDi>
    <basicUdiDi>8406821BUG00308HB</basicUdiDi>
    <tradeName>3.0T GEM Anterior Array</tradeName>
    <deviceName>3.0T GEM Suite</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5391454</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:50.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682100151</udiDi>
    <basicUdiDi>8406821BUG00396J2</basicUdiDi>
    <tradeName>Giraffe Stand-alone Infant Resuscitation System T-Piece</tradeName>
    <deviceName>Giraffe Stand-alone Infant Resuscitation System</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002206</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080499</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2082663-001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:47.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953001998</udiDi>
    <basicUdiDi>8406821BUG00310GW</basicUdiDi>
    <tradeName>1.5T AIR Posterior Array</tradeName>
    <deviceName>3.0T AIR Anterior/Posterior Arrays, 1.5T 30CH AIR AA, 1.5T AIR Posterior Array, and 3.0T AIR PA XL</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6015100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:45.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278788269</udiDi>
    <basicUdiDi>8406821BUG00401H2</basicUdiDi>
    <tradeName>NM/CT 870 DR</tradeName>
    <deviceName>NM/CT 870 DR</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3906FZ, H3906GA, H3906GB, H3906GC, H3906GD, H3906GE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:43.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278756138</udiDi>
    <basicUdiDi>8406821BUG00408HG</basicUdiDi>
    <tradeName>Invenia ABUS Prime</tradeName>
    <deviceName>Invenia ABUS</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>A56007000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:41.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278788252</udiDi>
    <basicUdiDi>8406821BUG00402H4</basicUdiDi>
    <tradeName>NM 830</tradeName>
    <deviceName>NM 830</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020105</emdnCode>
    <emdnDescription>FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3910AY, H3910AZ and H3910BA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:40.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278755544</udiDi>
    <basicUdiDi>8406821BUG00422HA</basicUdiDi>
    <tradeName>00195278755544</tradeName>
    <deviceName>StarGuide</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911BH</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:36.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278707871</udiDi>
    <basicUdiDi>8406821BUG00388J3</basicUdiDi>
    <tradeName>SIGNA Champion</tradeName>
    <deviceName>SIGNA Champion</deviceName>
    <manufacturerName>GE Healthcare Tianjin Company Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000001725</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Champion</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:17.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278685001</udiDi>
    <basicUdiDi>8406821BUG00455HR</basicUdiDi>
    <tradeName>OEC One ASD</tradeName>
    <deviceName>OEC One ASD</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>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OEC One ASD</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:12.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278674197</udiDi>
    <basicUdiDi>8406821BUG00379J2</basicUdiDi>
    <tradeName>LOGIQ</tradeName>
    <deviceName>LOGIQ e</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>Z11040103</emdnCode>
    <emdnDescription>PORTABLE ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOGIQ e TP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:10.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278672728</udiDi>
    <basicUdiDi>8406821BUG00380HK</basicUdiDi>
    <tradeName>Xeleris V Processing &amp; Review System</tradeName>
    <deviceName>Xeleris V Processing and Review System</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5927911-1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:08.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278672704</udiDi>
    <basicUdiDi>8406821BUG00349HR</basicUdiDi>
    <tradeName>NM/CT 870 DR</tradeName>
    <deviceName>NM/CT 870 DR</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>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H2402BG</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:06.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278670533</udiDi>
    <basicUdiDi>8406821BUG00276HP</basicUdiDi>
    <tradeName>REVOLUTION ASPIRE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wipro GE Medical Device manufacturing Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000045781</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>REVOLUTION ASPIRE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:04.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278665249</udiDi>
    <basicUdiDi>8406821BUG00313H4</basicUdiDi>
    <tradeName>48CH Head Coil</tradeName>
    <deviceName>3.0T 48CH Head Coil</deviceName>
    <manufacturerName>GE Healthcare Coils</manufacturerName>
    <manufacturerSrn>US-MF-000001664</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5930100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:04.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278664600</udiDi>
    <basicUdiDi>8406821BUG00347HM</basicUdiDi>
    <tradeName>00195278664600</tradeName>
    <deviceName>LOGIQ Totus, LOGIQ Totus HDU</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>MDR 2017/745</legislation>
    <emdnCode>Z11040101</emdnCode>
    <emdnDescription>INTERNAL ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOGIQ Totus/H46202LA</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:53:01.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278659446</udiDi>
    <basicUdiDi>8406821BUG00424HE</basicUdiDi>
    <tradeName>Portrait Core Services CSSXB</tradeName>
    <deviceName>Portrait Core Services</deviceName>
    <manufacturerName>GE Medical Systems Information Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017529</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1203020292</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5933539</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:52:57.620Z</lastUpdated>
  </row>
</eudamedExport>