<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278098603</udiDi>
    <basicUdiDi>8406821BUG00159HJ</basicUdiDi>
    <tradeName>Discovery MI Gen2</tradeName>
    <deviceName>Discovery MI Gen2</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCM-PET0009</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:40:51.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290016484007</udiDi>
    <basicUdiDi>7290016484SLG5</basicUdiDi>
    <tradeName>CardioGraphe</tradeName>
    <deviceName>SpotLight and CardioGraphe family of products</deviceName>
    <manufacturerName>Arineta</manufacturerName>
    <manufacturerSrn>IL-MF-000028266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07290016484007</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:19:18.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976302230022</udiDi>
    <basicUdiDi>69763022300000000000000T3</basicUdiDi>
    <tradeName>NeuWise PET/CT</tradeName>
    <deviceName>Positron Emission Tomography (PET) and Computed Tomography (CT) System</deviceName>
    <manufacturerName>Shenyang  Intelligent Neuclear Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038118</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:57:46.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974197600678</udiDi>
    <basicUdiDi>697419760PETNeurologyJQ</basicUdiDi>
    <tradeName>06974197600678</tradeName>
    <deviceName>PET/CT Image Analysis Software</deviceName>
    <manufacturerName>Shanghai United Imaging Intelligence Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035682</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020392</emdnCode>
    <emdnDescription>INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI303006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:49.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974197600371</udiDi>
    <basicUdiDi>697419760MIOncologyND</basicUdiDi>
    <tradeName>06974197600371</tradeName>
    <deviceName>PET/CT Computer-Aided Diagnostic Software</deviceName>
    <manufacturerName>Shanghai United Imaging Intelligence Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035682</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020392</emdnCode>
    <emdnDescription>INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI303002</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:28.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576834242</udiDi>
    <basicUdiDi>697157683424NN</basicUdiDi>
    <tradeName>06971576834242</tradeName>
    <deviceName></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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020392</emdnCode>
    <emdnDescription>INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001298</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:35.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576834068</udiDi>
    <basicUdiDi>697157683406NL</basicUdiDi>
    <tradeName>06971576834068</tradeName>
    <deviceName></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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11020392</emdnCode>
    <emdnDescription>INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000845</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:28.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832354</udiDi>
    <basicUdiDi>697157683235NH</basicUdiDi>
    <tradeName>06971576832354</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88002621</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:04.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832330</udiDi>
    <basicUdiDi>697157683233ND</basicUdiDi>
    <tradeName>06971576832330</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88002709</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:03.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832279</udiDi>
    <basicUdiDi>697157683227NJ</basicUdiDi>
    <tradeName>06971576832279</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88002513</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:06:02.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832262</udiDi>
    <basicUdiDi>697157683226NG</basicUdiDi>
    <tradeName>06971576832262</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88002589</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:58.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832255</udiDi>
    <basicUdiDi>697157683225NE</basicUdiDi>
    <tradeName>06971576832255</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88002512</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:57.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832231</udiDi>
    <basicUdiDi>697157683223NA</basicUdiDi>
    <tradeName>06971576832231</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88001221</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:56.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832187</udiDi>
    <basicUdiDi>697157683218NH</basicUdiDi>
    <tradeName>06971576832187</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000914</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:56.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832170</udiDi>
    <basicUdiDi>697157683217NF</basicUdiDi>
    <tradeName>06971576832170</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000908</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:40.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832163</udiDi>
    <basicUdiDi>697157683216ND</basicUdiDi>
    <tradeName>06971576832163</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000922</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:40.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832064</udiDi>
    <basicUdiDi>697157683206NA</basicUdiDi>
    <tradeName>06971576832064</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000192</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:36.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832040</udiDi>
    <basicUdiDi>697157683204N6</basicUdiDi>
    <tradeName>06971576832040</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000025</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:35.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832033</udiDi>
    <basicUdiDi>697157683203N4</basicUdiDi>
    <tradeName>06971576832033</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80512213</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:34.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576832026</udiDi>
    <basicUdiDi>697157683202N2</basicUdiDi>
    <tradeName>06971576832026</tradeName>
    <deviceName>Positron Emission Tomography and Computed Tomography 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>MDR 2017/745</legislation>
    <emdnCode>Z11020301</emdnCode>
    <emdnDescription>CT/PET SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000057</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:05:33.685Z</lastUpdated>
  </row>
</eudamedExport>