<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033837931379</udiDi>
    <basicUdiDi>803383793IMXRAYCTB001QS</basicUdiDi>
    <tradeName>NewTom 5G XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P70720008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:14:16.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837931348</udiDi>
    <basicUdiDi>803383793IMXRAYEXB002T2</basicUdiDi>
    <tradeName>NewTom VGi evo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P70700011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:14:12.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640178061491</udiDi>
    <basicUdiDi>764017806RollHolder2B</basicUdiDi>
    <tradeName>CT PaperRoll Holder C</tradeName>
    <deviceName>CT PaperRoll Holder</deviceName>
    <manufacturerName>Pearl Technology AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018100</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1272</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:39:55.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640178061446</udiDi>
    <basicUdiDi>764017806GantryCoverHT</basicUdiDi>
    <tradeName>CT Gantry Cover C33</tradeName>
    <deviceName>CT Gantry Cover</deviceName>
    <manufacturerName>Pearl Technology AG</manufacturerName>
    <manufacturerSrn>CH-MF-000018100</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1231-A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:39:53.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290020565006</udiDi>
    <basicUdiDi>7290020565VIEWER9D</basicUdiDi>
    <tradeName>CustoMED Viewer</tradeName>
    <deviceName>CustoMED Viewer</deviceName>
    <manufacturerName>CustoMED Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000050512</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07290020565006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:24:44.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018016176</udiDi>
    <basicUdiDi>7290018016HealthCCSng21NC</basicUdiDi>
    <tradeName>HealthCCSng</tradeName>
    <deviceName>HealthCCSng</deviceName>
    <manufacturerName>Nano-X AI Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000010234</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</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>HealthCCSng 2.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:35.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330208</udiDi>
    <basicUdiDi>697577533020PQ</basicUdiDi>
    <tradeName>06975775330208</tradeName>
    <deviceName>Coronary CT Image Intelligent 3D-reconstruction Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-Coronary 3D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:14.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330192</udiDi>
    <basicUdiDi>697577533019Q7</basicUdiDi>
    <tradeName>06975775330192</tradeName>
    <deviceName>Carotid CT Image Intelligent 3D-reconstruction Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-Carotid 3D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:14.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330147</udiDi>
    <basicUdiDi>697577533014PV</basicUdiDi>
    <tradeName>06975775330147</tradeName>
    <deviceName>CT Perfusion Image Processing Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-CT Perfusion Lite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:09.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330130</udiDi>
    <basicUdiDi>697577533013PT</basicUdiDi>
    <tradeName>06975775330130</tradeName>
    <deviceName>Liver CT Image Processing Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-Liver CT Lite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:08.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330123</udiDi>
    <basicUdiDi>697577533012PR</basicUdiDi>
    <tradeName>06975775330123</tradeName>
    <deviceName>Cardiac CT Image Processing Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-Cardiac Lite</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:07.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330093</udiDi>
    <basicUdiDi>697577533009Q4</basicUdiDi>
    <tradeName>06975775330093</tradeName>
    <deviceName>Picture Archiving and Communications System</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030692</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SenseCare-Pacs</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:06.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975066322011</udiDi>
    <basicUdiDi>697506632201UBX</basicUdiDi>
    <tradeName>Dental Cone-beam Computed Tomography</tradeName>
    <deviceName>Dental Cone-beam Computed Tomography</deviceName>
    <manufacturerName>Hefei Meyer Optoelectronic Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000029043</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030699</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-X9010DPro-3DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:03:16.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974692711190</udiDi>
    <basicUdiDi>697469271119PT</basicUdiDi>
    <tradeName>InferOperate®</tradeName>
    <deviceName>InferOperate Suite</deviceName>
    <manufacturerName>Infervision Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026583</manufacturerSrn>
    <authorisedRepresentativeName>Infervision Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023562</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>30458894</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:31.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974692710803</udiDi>
    <basicUdiDi>697469271083PX</basicUdiDi>
    <tradeName>InferOperate® Software</tradeName>
    <deviceName>InferOperate Software</deviceName>
    <manufacturerName>Infervision Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026583</manufacturerSrn>
    <authorisedRepresentativeName>Infervision Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023562</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30192180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:30.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974692710155</udiDi>
    <basicUdiDi>697469271015PE</basicUdiDi>
    <tradeName>InferRead® CT Rapid Triage</tradeName>
    <deviceName>Computer Aided Rapid Triage Software -InferRead® CT Rapid Triage</deviceName>
    <manufacturerName>Infervision Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026583</manufacturerSrn>
    <authorisedRepresentativeName>Infervision Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023562</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030682</emdnCode>
    <emdnDescription>COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30192180</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:29.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974692710094</udiDi>
    <basicUdiDi>697469271009PK</basicUdiDi>
    <tradeName>InferRead® CT Pneumonia</tradeName>
    <deviceName>Computer Aided Diagnostic Software InferRead® CT Pneumonia</deviceName>
    <manufacturerName>Infervision Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026583</manufacturerSrn>
    <authorisedRepresentativeName>Infervision Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023562</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>30192180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:24.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974692710087</udiDi>
    <basicUdiDi>697469271008PH</basicUdiDi>
    <tradeName>InferRead® CT Lung</tradeName>
    <deviceName>Computer Aided Diagnostic Software InferRead@ CT Lung</deviceName>
    <manufacturerName>Infervision Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026583</manufacturerSrn>
    <authorisedRepresentativeName>Infervision Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023562</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>30192180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:16:24.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974490210038</udiDi>
    <basicUdiDi>697449021SNVSYZ3581CS</basicUdiDi>
    <tradeName>16974490210038</tradeName>
    <deviceName>X-ray equipment for computed tomography</deviceName>
    <manufacturerName>SinoVision Healthcare (Yangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011927</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>AlphaCT 358 Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:22:47.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974490210014</udiDi>
    <basicUdiDi>697449021SNVSYZ3281CB</basicUdiDi>
    <tradeName>16974490210014</tradeName>
    <deviceName>X-ray equipment for computed tomography</deviceName>
    <manufacturerName>SinoVision Healthcare (Yangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011927</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>AlphaCT 328 Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:22:46.802Z</lastUpdated>
  </row>
</eudamedExport>