<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278481382</udiDi>
    <basicUdiDi>8406821BUG00286HS</basicUdiDi>
    <tradeName>SIGNA Artist Evo</tradeName>
    <deviceName>SIGNA Artist Evo</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 Artist Evo</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:26:59.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278510600</udiDi>
    <basicUdiDi>8406821BUG00080H4</basicUdiDi>
    <tradeName>READY View</tradeName>
    <deviceName>READY View</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>5890197</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:46.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278486813</udiDi>
    <basicUdiDi>8406821BUG00278HT</basicUdiDi>
    <tradeName>SIGNA Hero</tradeName>
    <deviceName>SIGNA Hero</deviceName>
    <manufacturerName>GE Medical Systems LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001632</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050105</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIGNA Hero</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:25.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964329018</udiDi>
    <basicUdiDi>693896432800PC</basicUdiDi>
    <tradeName>06938964329018</tradeName>
    <deviceName>Magnetic Resonance (MR) Systems</deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:21.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964322125</udiDi>
    <basicUdiDi>693896432200NE</basicUdiDi>
    <tradeName>06938964322125</tradeName>
    <deviceName>Magnetic Resonance (MR) Systems</deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:16.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964321012</udiDi>
    <basicUdiDi>693896432100N9</basicUdiDi>
    <tradeName>06938964321012</tradeName>
    <deviceName>Magnetic Resonance (MR) Systems</deviceName>
    <manufacturerName>Beijing Wandong Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014174</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:10:16.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596200711</udiDi>
    <basicUdiDi>457359620103000000000052V</basicUdiDi>
    <tradeName>APERTO Lucent</tradeName>
    <deviceName>APERTO Lucent</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APERTO Lucent</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:12:47.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596200674</udiDi>
    <basicUdiDi>457359620103000000000032R</basicUdiDi>
    <tradeName>AIRIS Vento</tradeName>
    <deviceName>AIRIS Vento</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIRIS Vento</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:12:46.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590630032</udiDi>
    <basicUdiDi>426059063000002AA</basicUdiDi>
    <tradeName>RöKo-Filling-Line 1</tradeName>
    <deviceName>Kontrastmittel-Applikations-Set 12h</deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>rkp-FL-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:28:35.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590630025</udiDi>
    <basicUdiDi>426059063000002AA</basicUdiDi>
    <tradeName>RöKo-Filling-Line 2M</tradeName>
    <deviceName>Kontrastmittel-Applikations-Set 12h</deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>rkp-FL-2M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:21:51.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260590630001</udiDi>
    <basicUdiDi>426059063000002AA</basicUdiDi>
    <tradeName>RöKo-Filling-Line 2</tradeName>
    <deviceName>Kontrastmittel-Applikations-Set 12h</deviceName>
    <manufacturerName>CARDEA GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006460</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050185</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>rkp-FL-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:12:37.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260486610216</udiDi>
    <basicUdiDi>426048661CoilsPK</basicUdiDi>
    <tradeName>NBAC 3.0T SMS Flex</tradeName>
    <deviceName>Magnetic Resonance (MR) Radiofrequency Volumetric Coils</deviceName>
    <manufacturerName>LMT Medical Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005238</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1105018001</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0800144</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-30T23:01:40.054Z</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>2026-07-30T20:49:24.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688323</udiDi>
    <basicUdiDi>8406821BUG00070GZ</basicUdiDi>
    <tradeName>FlightPlan for EVAR</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>5934738</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688347</udiDi>
    <basicUdiDi>8406821BUG00076HD</basicUdiDi>
    <tradeName>MR 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>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5934748</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688439</udiDi>
    <basicUdiDi>8406821BUG00080H4</basicUdiDi>
    <tradeName>READY View</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>5934750</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278688545</udiDi>
    <basicUdiDi>8406821BUG00072H5</basicUdiDi>
    <tradeName>GenIQ</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>5934740</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:24.191Z</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>00195278707741</udiDi>
    <basicUdiDi>08406821BUG004637C</basicUdiDi>
    <tradeName>00195278707741</tradeName>
    <deviceName>Digital Expert Access</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</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>5941611</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.477Z</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>2026-07-30T20:49:23.447Z</lastUpdated>
  </row>
</eudamedExport>