<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809278790055</udiDi>
    <basicUdiDi>B-08809278790055</basicUdiDi>
    <tradeName>08809278790055</tradeName>
    <deviceName>INFINITT 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>502</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:18.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809278790000</udiDi>
    <basicUdiDi>B-08809278790000</basicUdiDi>
    <tradeName>08809278790000</tradeName>
    <deviceName>STARPACS</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>401</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:23:16.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683210469618</udiDi>
    <basicUdiDi>B-08683210469618</basicUdiDi>
    <tradeName>RAD-X</tradeName>
    <deviceName>Radiological Pıcture Archiving and Communication System Rad-X</deviceName>
    <manufacturerName>Simplex Bilgi Teknolojileri A.Ş</manufacturerName>
    <manufacturerSrn>TR-MF-000043544</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>2.3.0</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:20:02.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594059060013</udiDi>
    <basicUdiDi>B-08594059060013</basicUdiDi>
    <tradeName>AMIS*PACS FLEXSERVER G2</tradeName>
    <deviceName>AMIS*PACS FlexServer G2</deviceName>
    <manufacturerName>ICZ.HEA a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001703</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>00003850</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:46:01.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>03800600006818</udiDi>
    <basicUdiDi>B-03800600006818</basicUdiDi>
    <tradeName>Software Company</tradeName>
    <deviceName>SC PACS</deviceName>
    <manufacturerName>"Софтуерна компания" ЕООД</manufacturerName>
    <manufacturerSrn>BG-MF-000024466</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>SCZFP2</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:36:51.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838100336</udiDi>
    <basicUdiDi>B-00884838100336</basicUdiDi>
    <tradeName>Vue PACS</tradeName>
    <deviceName>Vue PACS</deviceName>
    <manufacturerName>Philips Medical Systems Nederland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001489</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8986424</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:09:53.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00864058000395</udiDi>
    <basicUdiDi>B-00864058000395</basicUdiDi>
    <tradeName>Dentally Vision</tradeName>
    <deviceName>Dentally Vision</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>Dentally Vision</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:06.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000390</udiDi>
    <basicUdiDi>B-00863520000390</basicUdiDi>
    <tradeName>Simpleware ScanIP Medical</tradeName>
    <deviceName>Simpleware ScanIP Medical</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S-2021.06 -</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:59.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000383</udiDi>
    <basicUdiDi>B-00863520000383</basicUdiDi>
    <tradeName>Synopsys Simpleware™ ScanIP</tradeName>
    <deviceName>Synopsys Simpleware™ ScanIP</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R-2021.03</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:54.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000376</udiDi>
    <basicUdiDi>B-00863520000376</basicUdiDi>
    <tradeName>Simpleware ScanIP Medical</tradeName>
    <deviceName>Simpleware ScanIP Medical</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R-2020.09</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:53.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000369</udiDi>
    <basicUdiDi>B-00863520000369</basicUdiDi>
    <tradeName>Synopsys Simpleware™ ScanIP</tradeName>
    <deviceName>Synopsys Simpleware™ ScanIP</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Q-2020.03</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:52.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000352</udiDi>
    <basicUdiDi>B-00863520000352</basicUdiDi>
    <tradeName>Synopsys Simpleware™ ScanIP</tradeName>
    <deviceName>Synopsys Simpleware™ ScanIP</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Q-2020.06</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:51.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000345</udiDi>
    <basicUdiDi>B-00863520000345</basicUdiDi>
    <tradeName>Synopsys Simpleware™ ScanIP P-2019.09</tradeName>
    <deviceName>Synopsys Simpleware™ ScanIP P-2019.09</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P-2019.09</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:47.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863520000338</udiDi>
    <basicUdiDi>B-00863520000338</basicUdiDi>
    <tradeName>Synopsys Simpleware ScanIP™ O-2018.12</tradeName>
    <deviceName>Synopsys Simpleware ScanIP</deviceName>
    <manufacturerName>Synopsys (Northern Europe) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002376</manufacturerSrn>
    <authorisedRepresentativeName>Synopsys International Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001516</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>O-2018.12</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:47.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00854393006022</udiDi>
    <basicUdiDi>B-00854393006022</basicUdiDi>
    <tradeName>Velocity Medical Imaging Data Comparison Software</tradeName>
    <deviceName>Velocity</deviceName>
    <manufacturerName>Varian Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001784</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthineers Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000803</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Velocity 4.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:41.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850009343710</udiDi>
    <basicUdiDi>B-00850009343710</basicUdiDi>
    <tradeName>MIM configured for Elekta One</tradeName>
    <deviceName>MIM</deviceName>
    <manufacturerName>MIM Software Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007063</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6013646</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:52.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850009343352</udiDi>
    <basicUdiDi>B-00850009343352</basicUdiDi>
    <tradeName>MIM</tradeName>
    <deviceName>MIM</deviceName>
    <manufacturerName>MIM Software Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007063</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6003987</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:51.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850009343321</udiDi>
    <basicUdiDi>B-00850009343321</basicUdiDi>
    <tradeName>MIM</tradeName>
    <deviceName>MIM</deviceName>
    <manufacturerName>MIM Software Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007063</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6007898</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:50.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850009343307</udiDi>
    <basicUdiDi>B-00850009343307</basicUdiDi>
    <tradeName>Contour ProtégéAI+</tradeName>
    <deviceName>Contour ProtégéAI</deviceName>
    <manufacturerName>MIM Software Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007063</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6012418</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:46.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850009343277</udiDi>
    <basicUdiDi>B-00850009343277</basicUdiDi>
    <tradeName>00850009343277</tradeName>
    <deviceName>MIM</deviceName>
    <manufacturerName>MIM Software Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007063</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5995519</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:55:45.948Z</lastUpdated>
  </row>
</eudamedExport>