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<eudamedExport entity="devices">
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    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Volve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIDIA Volve-HT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:27.233Z</lastUpdated>
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  <row>
    <udiDi>08800018423202</udiDi>
    <basicUdiDi>88000184SMXXXXXXXXBV</basicUdiDi>
    <tradeName>AIDIA Nex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DRTECH Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000012441</manufacturerSrn>
    <authorisedRepresentativeName>DRTECH Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011974</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RMF-2000V</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:47:16.075Z</lastUpdated>
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  <row>
    <udiDi>06938964317091</udiDi>
    <basicUdiDi>693896431700NY</basicUdiDi>
    <tradeName>06938964317091</tradeName>
    <deviceName>Digital Mammography Systems</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>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:38:01.514Z</lastUpdated>
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  <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>04056869124575</udiDi>
    <basicUdiDi>0405686901979WW</basicUdiDi>
    <tradeName>MAMMOMAT Revelation</tradeName>
    <deviceName>MDR_18_II b_ERLN H 127_Mammo_digital</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>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11343300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:35.604Z</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>08800010320080</udiDi>
    <basicUdiDi>B-08800010320080</basicUdiDi>
    <tradeName>Digital Mammography X-ray system</tradeName>
    <deviceName>Pinkview-DR Plus</deviceName>
    <manufacturerName>BEMEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000013634</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Pinkview-DR Plus</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:59.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800010310043</udiDi>
    <basicUdiDi>B-08800010310043</basicUdiDi>
    <tradeName>Analog Mammography X-ray system</tradeName>
    <deviceName>Pinkview-AT</deviceName>
    <manufacturerName>BEMEMS CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000013634</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030201</emdnCode>
    <emdnDescription>CONVENTIONAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Pinkview-AT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:31:58.255Z</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>06950291110176</udiDi>
    <basicUdiDi>69502911MTQ</basicUdiDi>
    <tradeName>06950291110176</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator Star Care</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:08:26.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950291110473</udiDi>
    <basicUdiDi>69502911DR3YB</basicUdiDi>
    <tradeName>06950291110473</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sino Medical-Device Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007089</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navigator DR Care M</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-09T08:08:25.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>04630193910662</udiDi>
    <basicUdiDi>463019391HARMONIAW9</basicUdiDi>
    <tradeName>Harmonia DBT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0479E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:29.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>04630193910723</udiDi>
    <basicUdiDi>463019391HARMONIAW9</basicUdiDi>
    <tradeName>Harmonia B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0477E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:29.029Z</lastUpdated>
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  <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>
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  <row>
    <udiDi>06971576833054</udiDi>
    <basicUdiDi>B-06971576833054</basicUdiDi>
    <tradeName>06971576833054</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80506485</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:06:22.366Z</lastUpdated>
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  <row>
    <udiDi>D-06970021438196LX</udiDi>
    <basicUdiDi>B-06970021438196LX</basicUdiDi>
    <tradeName>Digital Mammography System</tradeName>
    <deviceName>Digital Mammography System</deviceName>
    <manufacturerName>HEDY Medical Device Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030128</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970021438196</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:35:45.542Z</lastUpdated>
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  <row>
    <udiDi>08809244065088</udiDi>
    <basicUdiDi>880924406HESTIALR</basicUdiDi>
    <tradeName>HESTIA</tradeName>
    <deviceName>HESITA</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>507</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:35.054Z</lastUpdated>
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  <row>
    <udiDi>08809244065026</udiDi>
    <basicUdiDi>880924406DMX600F7</basicUdiDi>
    <tradeName>DMX-600</tradeName>
    <deviceName>DMX-600</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030202</emdnCode>
    <emdnDescription>DIGITAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>506</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:33.562Z</lastUpdated>
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    <udiDi>08809244065019</udiDi>
    <basicUdiDi>880924406MX600EY</basicUdiDi>
    <tradeName>MX-600</tradeName>
    <deviceName>MX-600</deviceName>
    <manufacturerName>GENORAY CO., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000021014</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030201</emdnCode>
    <emdnDescription>CONVENTIONAL MAMMOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:47:31.059Z</lastUpdated>
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