<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884838111318</udiDi>
    <basicUdiDi>0884838BM1060LT</basicUdiDi>
    <tradeName>Philips CT 3500</tradeName>
    <deviceName>CT Scanner System (Philips CT 3500)</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>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728134</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:11:58.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838095168</udiDi>
    <basicUdiDi>0884838BM277T7</basicUdiDi>
    <tradeName>Philips CT Big Bore</tradeName>
    <deviceName>Philips CT Big Bore System</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>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728242</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:11:24.114Z</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>00884838059849</udiDi>
    <basicUdiDi>0884838BM284T4</basicUdiDi>
    <tradeName>Access CT</tradeName>
    <deviceName>CT Scanner System (Access CT)</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>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728116</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:46.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838059542</udiDi>
    <basicUdiDi>0884838BM280SU</basicUdiDi>
    <tradeName>IQon Spectral CT</tradeName>
    <deviceName>IQon Spectral CT System</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>Z11030605</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728332</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:45.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838059535</udiDi>
    <basicUdiDi>0884838BM286T8</basicUdiDi>
    <tradeName>MX 16-slice</tradeName>
    <deviceName>CT Scanner System (MX 16-slice)</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>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728131</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:41.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838059498</udiDi>
    <basicUdiDi>0884838BM279TB</basicUdiDi>
    <tradeName>Ingenuity Core</tradeName>
    <deviceName>Ingenuity CT System</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>Z11030601</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - NOT EXCEEDING 2 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728321</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:40.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838059474</udiDi>
    <basicUdiDi>0884838BM278T9</basicUdiDi>
    <tradeName>Brilliance iCT</tradeName>
    <deviceName>BRILLIANCE iCT SYSTEM</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>Z11030607</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728306</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:10:39.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>00882916000530</udiDi>
    <basicUdiDi>882916TRP68</basicUdiDi>
    <tradeName>TruPlan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Circle Cardiovascular Imaging Inc</manufacturerName>
    <manufacturerSrn>CA-MF-000011835</manufacturerSrn>
    <authorisedRepresentativeName>QDossier B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000033747</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v3.x</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:17:49.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953067550</udiDi>
    <basicUdiDi>08406821BUG005947U</basicUdiDi>
    <tradeName>Extremity Auto Views</tradeName>
    <deviceName>Extremity Auto Views</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5988229</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:57:57.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00198953050996</udiDi>
    <basicUdiDi>08406821BUG005937S</basicUdiDi>
    <tradeName>SnapShot Freeze</tradeName>
    <deviceName>SnapShot Freeze</deviceName>
    <manufacturerName>GE Medical Systems, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000018315</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5987386</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:57:49.499Z</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>00195278385215</udiDi>
    <basicUdiDi>08406821BUG005116W</basicUdiDi>
    <tradeName>Revolution Advance</tradeName>
    <deviceName>Revolution Advance</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>Z11030603</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Revolution Advance</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:56:26.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260483290213</udiDi>
    <basicUdiDi>0426048329VEO35</basicUdiDi>
    <tradeName>Veolity</tradeName>
    <deviceName>Veolity</deviceName>
    <manufacturerName>MeVis Medical Solutions AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005418</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Veo-2000-CS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:40:30.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869991771</udiDi>
    <basicUdiDi>0405686902238VL</basicUdiDi>
    <tradeName>myAblation Guide</tradeName>
    <deviceName>MDR_VT_IIb_ERLN_H_127_CTH_P10_Application Software</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>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10831373</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:05.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869295992</udiDi>
    <basicUdiDi>0405686902004UR</basicUdiDi>
    <tradeName>SOMATOM go.Now Combination</tradeName>
    <deviceName>CT-Scanner-COMBI_SHA NH</deviceName>
    <manufacturerName>Siemens Shanghai Medical Equipment Ltd.</manufacturerName>
    <manufacturerSrn>CN-PR-000020466</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>11061321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:52.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869267432</udiDi>
    <basicUdiDi>0405686901998X2</basicUdiDi>
    <tradeName>syngo.CT Cardiac Planning</tradeName>
    <deviceName>syngo.CT PP_IIb_App_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>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11546319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:49.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869267289</udiDi>
    <basicUdiDi>0405686900118UT</basicUdiDi>
    <tradeName>syngo.CT Coronary Analysis</tradeName>
    <deviceName>syngo.CT PP_IIa_App_ERLN H 127</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>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11546303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:55.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869051307</udiDi>
    <basicUdiDi>0405686900124UN</basicUdiDi>
    <tradeName>SOMATOM go.Now</tradeName>
    <deviceName>SOMATOM CT-Scanner_SHA NH</deviceName>
    <manufacturerName>Siemens Shanghai Medical Equipment Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013434</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</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>11061618</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:10:36.759Z</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>
</eudamedExport>