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<eudamedExport entity="devices">
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    <udiDi>D-DE-MF-000018915GS</udiDi>
    <basicUdiDi>B-DE-MF-000018915GS</basicUdiDi>
    <tradeName>Telemis</tradeName>
    <deviceName>Hyper.PACS</deviceName>
    <manufacturerName>Telemis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018915</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hyper.PACS V8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:05.081Z</lastUpdated>
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  <row>
    <udiDi>D-Bonelogic_Neuro_92</udiDi>
    <basicUdiDi>B-Bonelogic_Neuro_92</basicUdiDi>
    <tradeName>Bonelogic Neuro</tradeName>
    <deviceName>Bonelogic Neuro</deviceName>
    <manufacturerName>Disior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bonelogic Neuro</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:32:12.013Z</lastUpdated>
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  <row>
    <udiDi>D-Bonelogic_CMFOrbital_WP</udiDi>
    <basicUdiDi>B-Bonelogic_CMFOrbital_WP</basicUdiDi>
    <tradeName>Bonelogic CMF Orbital</tradeName>
    <deviceName>Bonelogic CMF Orbital</deviceName>
    <manufacturerName>Disior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bonelogic CMF Orbital</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:32:11.219Z</lastUpdated>
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  <row>
    <udiDi>09120100700240</udiDi>
    <basicUdiDi>912010070aimHG</basicUdiDi>
    <tradeName>synedra AIM 24 Herakles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>synedra information technologies GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 Herakles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:36.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120100700257</udiDi>
    <basicUdiDi>912010070aimHG</basicUdiDi>
    <tradeName>synedra AIM 25 Rhea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>synedra information technologies GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Rhea</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:36.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120100701254</udiDi>
    <basicUdiDi>912010070viewproW6</basicUdiDi>
    <tradeName>synedra View Professional 25 Rhea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>synedra information technologies GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Rhea</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:36.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2106845-xPG</udiDi>
    <basicUdiDi>B-2106845-xPG</basicUdiDi>
    <tradeName>Centricity Enterprise Web 4.0</tradeName>
    <deviceName>Centricity Enterprise Web</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2049944-x, 2068692-x</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:27:20.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2052421-xMG</udiDi>
    <basicUdiDi>B-2052421-xMG</basicUdiDi>
    <tradeName>Centricity PACS - RA1000 v3.0</tradeName>
    <deviceName>Centricity PACS</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2051372-x, 2051378-x</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:15.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2027870-xQ8</udiDi>
    <basicUdiDi>B-2027870-xQ8</basicUdiDi>
    <tradeName>Centricity Enterprise Web 3.0</tradeName>
    <deviceName>Centricity Enterprise Web</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2027870-x</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:02.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2022296-xMH</udiDi>
    <basicUdiDi>B-2022296-xMH</basicUdiDi>
    <tradeName>Centricity Radiology RA600 v7.0; Centricity Cardiology CA1000 v1.0; Centricity Digital Hardcopy (DHC) v1.0</tradeName>
    <deviceName>Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy</deviceName>
    <manufacturerName>GE Healthcare</manufacturerName>
    <manufacturerSrn>US-MF-000001862</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2022296-x</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:28:00.249Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421904268333</udiDi>
    <basicUdiDi>B-09421904268333</basicUdiDi>
    <tradeName>Volpara Scorecard</tradeName>
    <deviceName>Volpara Imaging Software</deviceName>
    <manufacturerName>Lunit International Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000004537</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4.5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:54:02.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421904268241</udiDi>
    <basicUdiDi>B-09421904268241</basicUdiDi>
    <tradeName>Volpara Scorecard</tradeName>
    <deviceName>Volpara Imaging Software</deviceName>
    <manufacturerName>Lunit International Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000004537</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4.4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:54:01.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885017050000</udiDi>
    <basicUdiDi>B-08885017050000</basicUdiDi>
    <tradeName>08885017050000</tradeName>
    <deviceName>BioMind Diagnostic Support Software</deviceName>
    <manufacturerName>Hanalytics Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000016821</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02C001BRO01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:02.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809394330388</udiDi>
    <basicUdiDi>B-08809394330388</basicUdiDi>
    <tradeName>QXLink</tradeName>
    <deviceName>QXLink</deviceName>
    <manufacturerName>Vieworks Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020017</manufacturerSrn>
    <authorisedRepresentativeName>Vieworks EU GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000052174</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QXLink</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:01.362Z</lastUpdated>
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  <row>
    <udiDi>08809278790307</udiDi>
    <basicUdiDi>B-08809278790307</basicUdiDi>
    <tradeName>08809278790307</tradeName>
    <deviceName>Xelis Dental</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>602</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:41.522Z</lastUpdated>
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  <row>
    <udiDi>08809278790130</udiDi>
    <basicUdiDi>B-08809278790130</basicUdiDi>
    <tradeName>08809278790130</tradeName>
    <deviceName>INFINITT PACS 7.0</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:39.123Z</lastUpdated>
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  <row>
    <udiDi>08809278790192</udiDi>
    <basicUdiDi>B-08809278790192</basicUdiDi>
    <tradeName>08809278790192</tradeName>
    <deviceName>INFINITT RT PACS</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:36.808Z</lastUpdated>
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  <row>
    <udiDi>08809278790123</udiDi>
    <basicUdiDi>B-08809278790123</basicUdiDi>
    <tradeName>08809278790123</tradeName>
    <deviceName>INFINITT ULite</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:23.058Z</lastUpdated>
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    <udiDi>08809278790079</udiDi>
    <basicUdiDi>B-08809278790079</basicUdiDi>
    <tradeName>08809278790079</tradeName>
    <deviceName>Xelis</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:20.660Z</lastUpdated>
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  <row>
    <udiDi>08809278790062</udiDi>
    <basicUdiDi>B-08809278790062</basicUdiDi>
    <tradeName>08809278790062</tradeName>
    <deviceName>INFINITT Cardiology PACS</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:19.073Z</lastUpdated>
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