<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00195278379610</udiDi>
    <basicUdiDi>B-00195278379610</basicUdiDi>
    <tradeName>Universal Viewer v8</tradeName>
    <deviceName>Universal Viewer</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>K2049DE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:40.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00195278011343</udiDi>
    <basicUdiDi>B-00195278011343</basicUdiDi>
    <tradeName>DaTQUANT</tradeName>
    <deviceName>DaTQUANT</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3901ZD</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:28.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-000033465DX</udiDi>
    <basicUdiDi>B-000033465DX</basicUdiDi>
    <tradeName>X-Store Web</tradeName>
    <deviceName>X-Store Web</deviceName>
    <manufacturerName>M.I. Medical S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000033465</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>109660</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:00:23.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-(01)00864058000302GR</udiDi>
    <basicUdiDi>B-(01)00864058000302GR</basicUdiDi>
    <tradeName>Dentally Vision (previously marketed as Dentrix Ascend Imaging)</tradeName>
    <deviceName>Dentally Vision (previously marketed as Dentrix Ascend Imaging)</deviceName>
    <manufacturerName>Henry Schein One, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000038317</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:30:53.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>09369900041935</udiDi>
    <basicUdiDi>93623480RSPSW001GE</basicUdiDi>
    <tradeName>Navbit Rapid Surgical Plan</tradeName>
    <deviceName>Navbit Rapid Surgical Plan</deviceName>
    <manufacturerName>Navbit Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016920</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSP-SW-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:09:07.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>09358996000018</udiDi>
    <basicUdiDi>9358996000001D9</basicUdiDi>
    <tradeName>Zed Link</tradeName>
    <deviceName>Zed Link</deviceName>
    <manufacturerName>Zed Technologies Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000034171</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZEDLINK</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:08:20.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908026312003</udiDi>
    <basicUdiDi>8908026312ED001V7</basicUdiDi>
    <tradeName>RadSmart</tradeName>
    <deviceName>RadSmart</deviceName>
    <manufacturerName>ENDIMENSION TECHNOLOGY PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000046858</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RadSmart Version 1.0.0</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:09:05.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908023670021</udiDi>
    <basicUdiDi>8908023670DT0042M</basicUdiDi>
    <tradeName>08908023670021</tradeName>
    <deviceName>Genki Edge</deviceName>
    <manufacturerName>DeepTek Medical Imaging Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040297</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DeepTek_004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:39.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908023670014</udiDi>
    <basicUdiDi>8908023670DT0032K</basicUdiDi>
    <tradeName>08908023670014</tradeName>
    <deviceName>DeepTek CXR AI</deviceName>
    <manufacturerName>DeepTek Medical Imaging Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040297</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DeepTek_003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:39.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908023670007</udiDi>
    <basicUdiDi>8908023670DT0012F</basicUdiDi>
    <tradeName>08908023670007</tradeName>
    <deviceName>Augmento</deviceName>
    <manufacturerName>DeepTek Medical Imaging Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000040297</manufacturerSrn>
    <authorisedRepresentativeName>Specculo Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000034988</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DeepTek_001</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:35.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>08908008302008</udiDi>
    <basicUdiDi>8908008302RADSpaH6</basicUdiDi>
    <tradeName>RADSpa</tradeName>
    <deviceName>RADSpa®</deviceName>
    <manufacturerName>Telerad Tech Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000026224</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>RADSpa®</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:20.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08906172310010</udiDi>
    <basicUdiDi>890617231XRM1M3</basicUdiDi>
    <tradeName>EPSILON HEALTHCARE SOLUTIONS PRIVATE LIMITED</tradeName>
    <deviceName>EPCORSA 15 / Astro 15</deviceName>
    <manufacturerName>EPSILON HEALTHCARE SOLUTIONS  PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034860</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069005</emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPCORSA 15 / Astro 15</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:46:47.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809972790009</udiDi>
    <basicUdiDi>880997279DSI-100X2</basicUdiDi>
    <tradeName>FREEDOM i</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>DOF Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000041580</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069001</emdnCode>
    <emdnDescription>BIOIMAGING PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSI-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:06:08.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809278790154</udiDi>
    <basicUdiDi>880927879DoseM85</basicUdiDi>
    <tradeName>08809278790154</tradeName>
    <deviceName>INFINITT DoseM</deviceName>
    <manufacturerName>INFINITT Healthcare Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000010998</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1307</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:50:15.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800252360004</udiDi>
    <basicUdiDi>880025236CONKCB</basicUdiDi>
    <tradeName>CONNEVO KOA</tradeName>
    <deviceName>CONNEVO KOA</deviceName>
    <manufacturerName>CONNECTEVE Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000043802</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CONK01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:36:18.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076000094</udiDi>
    <basicUdiDi>88000760CXRXN</basicUdiDi>
    <tradeName>Lunit INSIGHT CXR</tradeName>
    <deviceName>Lunit INSIGHT CXR</deviceName>
    <manufacturerName>Lunit Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000005200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:20.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076000056</udiDi>
    <basicUdiDi>88000760MMGXH</basicUdiDi>
    <tradeName>Lunit INSIGHT MMG</tradeName>
    <deviceName>Lunit INSIGHT MMG</deviceName>
    <manufacturerName>Lunit Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000005200</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>124012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:19.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045800113</udiDi>
    <basicUdiDi>88000458VCXZ8</basicUdiDi>
    <tradeName>08800045800113</tradeName>
    <deviceName>VUNO Med-Chest X-ray</deviceName>
    <manufacturerName>VUNO Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN-M-02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:01.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045800106</udiDi>
    <basicUdiDi>88000458VDPYT</basicUdiDi>
    <tradeName>08800045800106</tradeName>
    <deviceName>VUNO Med-DeepBrain</deviceName>
    <manufacturerName>VUNO Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN-M-06</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:47.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800045800083</udiDi>
    <basicUdiDi>88000458VLCYR</basicUdiDi>
    <tradeName>08800045800083</tradeName>
    <deviceName>VUNO Med-LungCT AI</deviceName>
    <manufacturerName>VUNO Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022266</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VN-M-04</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:45.165Z</lastUpdated>
  </row>
</eudamedExport>