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<eudamedExport entity="devices">
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    <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>09120105730846</udiDi>
    <basicUdiDi>912010573IBLABFROGRB</basicUdiDi>
    <tradeName>IB Lab FROG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IB Lab GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000006554</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V1.1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:36.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120122170021</udiDi>
    <basicUdiDi>912012217SHLVIEW4SG</basicUdiDi>
    <tradeName>SHLView Version 4.07</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHL Solutions for Healthcare and Life-Sciences GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000004566</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHLVIEW4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:31.326Z</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>15060484490089</udiDi>
    <basicUdiDi>B-15060484490089</basicUdiDi>
    <tradeName>moorLDLS-BI</tradeName>
    <deviceName>moorLDLS-BI Laser Doppler Burns Imager and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>moorLDLS-BI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:06.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060484490072</udiDi>
    <basicUdiDi>B-15060484490072</basicUdiDi>
    <tradeName>moorLDI2-BI</tradeName>
    <deviceName>moorLDI2-BI Laser Doppler Burns Imager and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>moorLDI2-BI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:05.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060484490041</udiDi>
    <basicUdiDi>B-15060484490041</basicUdiDi>
    <tradeName>moorFLPI-2</tradeName>
    <deviceName>moorFLPI-2 and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>moorFLPI-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:01.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>13700550400773</udiDi>
    <basicUdiDi>B-13700550400773</basicUdiDi>
    <tradeName>IDC</tradeName>
    <deviceName>Injector Data Collector</deviceName>
    <manufacturerName>MEDEX</manufacturerName>
    <manufacturerSrn>FR-MF-000000414</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T03:06:59.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311643DW074083</udiDi>
    <basicUdiDi>B-1311643DW074083</basicUdiDi>
    <tradeName>1311643DW074083</tradeName>
    <deviceName>MERLIN Diagnostic Workcenter</deviceName>
    <manufacturerName>Phönix-PACS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:50.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311643DW073070</udiDi>
    <basicUdiDi>B-1311643DW073070</basicUdiDi>
    <tradeName>1311643DW073070</tradeName>
    <deviceName>MERLIN Diagnostic Workcenter</deviceName>
    <manufacturerName>Phönix-PACS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:49.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311643DW071044</udiDi>
    <basicUdiDi>B-1311643DW071044</basicUdiDi>
    <tradeName>1311643DW071044</tradeName>
    <deviceName>MERLIN Diagnostic Workcenter</deviceName>
    <manufacturerName>Phönix-PACS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:45.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311643DW070031</udiDi>
    <basicUdiDi>B-1311643DW070031</basicUdiDi>
    <tradeName>1311643DW070031</tradeName>
    <deviceName>MERLIN Diagnostic Workcenter</deviceName>
    <manufacturerName>Phönix-PACS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:44.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311643DW05821</udiDi>
    <basicUdiDi>B-1311643DW05821</basicUdiDi>
    <tradeName>1311643DW05821</tradeName>
    <deviceName>MERLIN Diagnostic Workcenter</deviceName>
    <manufacturerName>Phönix-PACS GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5.8.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:43.876Z</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>
</eudamedExport>