<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B885MAML2EU0</udiDi>
    <basicUdiDi>++B885MAMMOSCREENQB</basicUdiDi>
    <tradeName>MammoScreen</tradeName>
    <deviceName>MammoScreen</deviceName>
    <manufacturerName>THERAPIXEL SA</manufacturerName>
    <manufacturerSrn>FR-MF-000035499</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAML</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-23T16:01:29.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869225333</udiDi>
    <basicUdiDi>0405686901980WF</basicUdiDi>
    <tradeName>syngo.Breast Care</tradeName>
    <deviceName>MDR_18_II b_ERLN H 127_WHSAMD</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>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11343179</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:43.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>B148CADONE3260</udiDi>
    <basicUdiDi>++B148CADONE3260VK</basicUdiDi>
    <tradeName>CadOne</tradeName>
    <deviceName>CadOne</deviceName>
    <manufacturerName>Three Palm Software</manufacturerName>
    <manufacturerSrn>US-MF-000002924</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAD1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:52:35.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326450131</udiDi>
    <basicUdiDi>B-08719326450131</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName>Transpara</deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Version 1.7.0 and 1.7.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:05.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326450117</udiDi>
    <basicUdiDi>B-08719326450117</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName>Transpara</deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Version 1.6.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:01.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971576834051</udiDi>
    <basicUdiDi>B-06971576834051</basicUdiDi>
    <tradeName>06971576834051</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>MDD</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88000075</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:06:31.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720387058044</udiDi>
    <basicUdiDi>8720387058Transpara_V2D5</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName>Transpara</deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.0.0</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:40.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720387058013</udiDi>
    <basicUdiDi>87203870580TransparaDY</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName>Transpara</deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.7.3 and 1.7.4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:39.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056977360335</udiDi>
    <basicUdiDi>805697736TZNVT</basicUdiDi>
    <tradeName>IMS GIOTTO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IMS GIOTTO S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025920</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>31014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:22:57.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053608200053</udiDi>
    <basicUdiDi>805360820GS-EYERAD27</basicUdiDi>
    <tradeName>EyeRad</tradeName>
    <deviceName>EyeRad</deviceName>
    <manufacturerName>G-Squared SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000016857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeRad 3.1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:44:42.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974197600692</udiDi>
    <basicUdiDi>697419760CPortalMammo7R</basicUdiDi>
    <tradeName>06974197600692</tradeName>
    <deviceName>Mammo 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>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AI303008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:47.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260732180043</udiDi>
    <basicUdiDi>426073218VaraAIUJ</basicUdiDi>
    <tradeName>Vara AI</tradeName>
    <deviceName>Vara AI</deviceName>
    <manufacturerName>MX Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:03:54.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260732180005</udiDi>
    <basicUdiDi>426073218VARAA3</basicUdiDi>
    <tradeName>Vara MG</tradeName>
    <deviceName>Vara MG</deviceName>
    <manufacturerName>MX Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:03:51.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720387058051</udiDi>
    <basicUdiDi>8720387058Transpara_V2D5</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.y.z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:01.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720387058068</udiDi>
    <basicUdiDi>8720387058Transpara_V2D5</basicUdiDi>
    <tradeName>Transpara</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScreenPoint Medical</manufacturerName>
    <manufacturerSrn>NL-MF-000000241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.y.z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:58:01.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869299297</udiDi>
    <basicUdiDi>0405686901980WF</basicUdiDi>
    <tradeName>MAMMOVISTA B.smart</tradeName>
    <deviceName></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>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11647802</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:14.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260732180036</udiDi>
    <basicUdiDi>426073218VARAA3</basicUdiDi>
    <tradeName>Vara MG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MX Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030292</emdnCode>
    <emdnDescription>MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T01:44:50.791Z</lastUpdated>
  </row>
</eudamedExport>