<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278469700</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Select</tradeName>
    <deviceName>Revolution Apex Select</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Power Xtream: B7919QT; Power Pro: B7919QS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:17:18.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596204382</udiDi>
    <basicUdiDi>45735962010100000000001Y8</basicUdiDi>
    <tradeName>FCT iStream</tradeName>
    <deviceName>FCT iStream</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCT iStream</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:11:08.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>04573596200544</udiDi>
    <basicUdiDi>457359620X-ray_CTZU</basicUdiDi>
    <tradeName>SCENARIA View</tradeName>
    <deviceName>SCENARIA View</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCENARIA View</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:09:48.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278633149</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Expert</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Apex Expert</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:25.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278718129</udiDi>
    <basicUdiDi>8406821BUG00117H2</basicUdiDi>
    <tradeName>Revolution Ascend Elite</tradeName>
    <deviceName>Revolution Ascend</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Ascend Elite</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278718136</udiDi>
    <basicUdiDi>8406821BUG00117H2</basicUdiDi>
    <tradeName>Revolution Ascend Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Ascend Plus</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278718204</udiDi>
    <basicUdiDi>8406821BUG00117H2</basicUdiDi>
    <tradeName>Revolution Ascend Select</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Ascend Select</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:23.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278788665</udiDi>
    <basicUdiDi>8406821BUG00213GX</basicUdiDi>
    <tradeName>Revolution Apex Select with Plus Edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Apex Select with Plus Edition</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:22.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278882677</udiDi>
    <basicUdiDi>08406821BUG004897W</basicUdiDi>
    <tradeName>Console Generation Upgrade</tradeName>
    <deviceName>Console Generation Upgrade</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Console Generation Upgrade</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:20.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278923257</udiDi>
    <basicUdiDi>08406821BUG004907F</basicUdiDi>
    <tradeName>Revolution Maxima</tradeName>
    <deviceName>Revolution Maxima</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Maxima</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:49:19.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151994995</udiDi>
    <basicUdiDi>0405686902298W6</basicUdiDi>
    <tradeName>SOMATOM X.cite</tradeName>
    <deviceName>MDR_03_II b_FOR S3_CT_Scanner</deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11330001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:29:49.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938964326017</udiDi>
    <basicUdiDi>693896432600P2</basicUdiDi>
    <tradeName>06938964326017</tradeName>
    <deviceName>Computed Tomographs</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:38:03.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838129528</udiDi>
    <basicUdiDi>0884838BM1701ME</basicUdiDi>
    <tradeName>CT Rembra</tradeName>
    <deviceName>CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra)</deviceName>
    <manufacturerName>Philips Healthcare (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003923</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728383</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:13:52.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838085015</udiDi>
    <basicUdiDi>0884838BM285T6</basicUdiDi>
    <tradeName>Incisive CT</tradeName>
    <deviceName>CT Scanner System (Incisive CT/CT5300)</deviceName>
    <manufacturerName>Philips Healthcare (Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003923</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728143</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:11:00.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953018989</udiDi>
    <basicUdiDi>08406821BUG0060578</basicUdiDi>
    <tradeName>Revolution Altitude Plus</tradeName>
    <deviceName>Revolution Altitude Family</deviceName>
    <manufacturerName>GE HANGWEI MEDICAL SYSTEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009292</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Altitude Plus</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:57:24.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869003665</udiDi>
    <basicUdiDi>0405686900117UR</basicUdiDi>
    <tradeName>SOMATOM Definition AS</tradeName>
    <deviceName>CT-Scanner_IIb_ERLN H 127</deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08098027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:23.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OptimaCT660WA</udiDi>
    <basicUdiDi>B-OptimaCT660WA</basicUdiDi>
    <tradeName>Optima CT660</tradeName>
    <deviceName>Optima CT660</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Optima CT660</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:15:44.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831050</udiDi>
    <basicUdiDi>B-06971576831050</basicUdiDi>
    <tradeName>06971576831050</tradeName>
    <deviceName>Computed Tomography X-ray System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80513129</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:06:13.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576831043</udiDi>
    <basicUdiDi>B-06971576831043</basicUdiDi>
    <tradeName>06971576831043</tradeName>
    <deviceName>Computed Tomography X-ray System</deviceName>
    <manufacturerName>Shanghai United Imaging Healthcare Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008501</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80000063</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:06:13.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840682109796</udiDi>
    <basicUdiDi>B-00840682109796</basicUdiDi>
    <tradeName>Revolution EVO</tradeName>
    <deviceName>Revolution EVO</deviceName>
    <manufacturerName>GE Healthcare Japan Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000009291</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030606</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution EVO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:38:26.949Z</lastUpdated>
  </row>
</eudamedExport>