<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278616845</udiDi>
    <basicUdiDi>8406821BUG00328HH</basicUdiDi>
    <tradeName>SIGNA Victor</tradeName>
    <deviceName>SIGNA Victor</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 Victor</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:27:37.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278577238</udiDi>
    <basicUdiDi>8406821BUG00303GZ</basicUdiDi>
    <tradeName>SIGNA Creator</tradeName>
    <deviceName></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 Creator</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:27:32.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278577221</udiDi>
    <basicUdiDi>8406821BUG00304H3</basicUdiDi>
    <tradeName>SIGNA Explorer</tradeName>
    <deviceName></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 Explorer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:27:31.483Z</lastUpdated>
  </row>
  <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>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>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>
  <row>
    <udiDi>00195278929518</udiDi>
    <basicUdiDi>08406821BUG0052579</basicUdiDi>
    <tradeName>SIGNA Sprint</tradeName>
    <deviceName>SIGNA Sprint</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 Sprint</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:18.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151047813</udiDi>
    <basicUdiDi>0405686900126US</basicUdiDi>
    <tradeName>MAGNETOM Flow.Ace</tradeName>
    <deviceName>MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013436</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</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>11571131</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:29:43.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151017397</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Flow.Plus Z</tradeName>
    <deviceName>MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11571638</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:29:22.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838098275</udiDi>
    <basicUdiDi>0884838BM697TZ</basicUdiDi>
    <tradeName>Ingenia 1.5T</tradeName>
    <deviceName>Magnetic Resonance Imaging Systems</deviceName>
    <manufacturerName>Philips Medical Systems Nederland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</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>782101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:21:45.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838075238</udiDi>
    <basicUdiDi>0884838BM938TY</basicUdiDi>
    <tradeName>Marlin 1.5T</tradeName>
    <deviceName>Marlin 1.5T</deviceName>
    <manufacturerName>Philips Medical Systems Nederland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</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>781474</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:20:02.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850043319009</udiDi>
    <basicUdiDi>0860000606100001R3</basicUdiDi>
    <tradeName>Swoop® Portable MR Imaging® System</tradeName>
    <deviceName>Swoop® Portable MR Imaging® System</deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>900-11001-06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:48:37.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278601162</udiDi>
    <basicUdiDi>08406821BUG004837J</basicUdiDi>
    <tradeName>SIGNA Prime Elite</tradeName>
    <deviceName>SIGNA Prime Elite</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 Prime Elite</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:56:26.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869997094</udiDi>
    <basicUdiDi>0405686902279W2</basicUdiDi>
    <tradeName>MAGNETOM Free.XL</tradeName>
    <deviceName>MDR_02_IIa_FOR AG S3_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11690226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:11.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869265841</udiDi>
    <basicUdiDi>0405686900131UK</basicUdiDi>
    <tradeName>MAGNETOM Amira</tradeName>
    <deviceName>MDR_02_SPPP_IIa_SZN G MR_Comb.Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020467</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11568941</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:44.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869006819</udiDi>
    <basicUdiDi>0405686900126US</basicUdiDi>
    <tradeName>MAGNETOM Amira</tradeName>
    <deviceName>MDR_02_IIa_SZN G MR ERL H 127_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Shenzhen Magnetic Resonance Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013436</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</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>10836777</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:30.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869006697</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Aera</tradeName>
    <deviceName>MDR_02_IIa_ERLN H 127_ACDV_Magnetom</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>10432914</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:23.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151995114</udiDi>
    <basicUdiDi>0405686902279W2</basicUdiDi>
    <tradeName>MAGNETOM Altea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11344915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869230726</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Altea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11410371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:32.554Z</lastUpdated>
  </row>
</eudamedExport>