<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07350002332030</udiDi>
    <basicUdiDi>73500023323E</basicUdiDi>
    <tradeName>aBSI</tradeName>
    <deviceName>aBSI</deviceName>
    <manufacturerName>EXINI Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001840</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>203</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:46:44.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747185829</udiDi>
    <basicUdiDi>733274700000016275</basicUdiDi>
    <tradeName>IPS CaseDesigner 2.3 for Windows 64-bit</tradeName>
    <deviceName>Diagnostic and treatment software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300011_V2.3_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:59.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747181937</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Implant 3.6 for Win 64-bit</tradeName>
    <deviceName>Diagnostic and treatment software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300843_V3.6_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:58.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747180756</udiDi>
    <basicUdiDi>73327470000002146X</basicUdiDi>
    <tradeName>DTX Studio Lab 1.12 for Windows 64-bit</tradeName>
    <deviceName>Design software</deviceName>
    <manufacturerName>Nobel Biocare AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000009</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300607_V1.12_WIN64</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:10:54.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018862018</udiDi>
    <basicUdiDi>729001886201CR</basicUdiDi>
    <tradeName>HOLOSCOPE-i</tradeName>
    <deviceName>HOLOSCOPE</deviceName>
    <manufacturerName>Real View Imaging Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000013100</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069099</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYS000002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:23:09.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018052310</udiDi>
    <basicUdiDi>7290018052BC.TRGSU</basicUdiDi>
    <tradeName>Briefcase-Triage</tradeName>
    <deviceName>BriefCase-Triage</deviceName>
    <manufacturerName>Aidoc Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000030988</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>BC.TRG</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:41.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018052266</udiDi>
    <basicUdiDi>7290018052BC.QTFSH</basicUdiDi>
    <tradeName>BriefCase-Quantification</tradeName>
    <deviceName>BriefCase-Quantification</deviceName>
    <manufacturerName>Aidoc Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000030988</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>BC-QTF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:39.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018052198</udiDi>
    <basicUdiDi>729001805219AD</basicUdiDi>
    <tradeName>aiOS</tradeName>
    <deviceName>aiOS</deviceName>
    <manufacturerName>Aidoc Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000030988</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>aiOS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:35.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970353803068</udiDi>
    <basicUdiDi>697035380304478</basicUdiDi>
    <tradeName>Vein Finder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qingdao Hiprove Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024223</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069099</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HV-600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:40:02.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977207040037</udiDi>
    <basicUdiDi>697720704SOFTWARE002V8</basicUdiDi>
    <tradeName>06977207040037</tradeName>
    <deviceName>Orthodontic Treatment Planning Software</deviceName>
    <manufacturerName>Shanghai EA Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040940</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>iOrtho Platform</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:09.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977207040020</udiDi>
    <basicUdiDi>697720704SOFTWARE001V6</basicUdiDi>
    <tradeName>06977207040020</tradeName>
    <deviceName>Orthodontic Treatment Planning Software</deviceName>
    <manufacturerName>Shanghai EA Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040940</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>iOrtho</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:19:08.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976986101011</udiDi>
    <basicUdiDi>697698610IS01SU</basicUdiDi>
    <tradeName>3dmakerpro</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>Wuhan Ruler Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038827</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JMO1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:39.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976982090913</udiDi>
    <basicUdiDi>6976982093DEFCSN3</basicUdiDi>
    <tradeName>4K 3D Endoscopic Fluorescence Camera System</tradeName>
    <deviceName>4K 3D Endoscopic Fluorescence Camera System</deviceName>
    <manufacturerName>Shinevia (Shandong) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049465</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069080</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HORUS CAM-4030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:38.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976982090876</udiDi>
    <basicUdiDi>697698209EFCSU9</basicUdiDi>
    <tradeName>4K endoscopic fluorescence camera system</tradeName>
    <deviceName>4K endoscopic fluorescence camera system</deviceName>
    <manufacturerName>Shinevia (Shandong) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049465</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069080</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HORUS CAM-4100A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:34.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976982090814</udiDi>
    <basicUdiDi>697698209FCSY5</basicUdiDi>
    <tradeName>Fluorescence Camera System</tradeName>
    <deviceName>Fluorescence Camera System</deviceName>
    <manufacturerName>Shinevia (Shandong) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049465</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069080</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARGOS NIR-300PT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:33.305Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976982090807</udiDi>
    <basicUdiDi>697698209PIS2C</basicUdiDi>
    <tradeName>Parathyroid Imaging System</tradeName>
    <deviceName>Parathyroid Imaging System</deviceName>
    <manufacturerName>Shinevia (Shandong) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049465</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008964</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069080</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - HARDWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARGOS-200PT</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:32.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976365389996</udiDi>
    <basicUdiDi>697636538999R9</basicUdiDi>
    <tradeName>image plate scanner</tradeName>
    <deviceName>image plate scanner</deviceName>
    <manufacturerName>Inpixel Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039577</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPS1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:04:28.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976359710034</udiDi>
    <basicUdiDi>697635971RRTZT</basicUdiDi>
    <tradeName>06976359710034</tradeName>
    <deviceName>Fundus Image Processing Software</deviceName>
    <manufacturerName>Hangzhou AI-MU Meditec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036109</manufacturerSrn>
    <authorisedRepresentativeName>Everbiz GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000035279</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z110603</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:03:59.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975775330154</udiDi>
    <basicUdiDi>697577533015PX</basicUdiDi>
    <tradeName>06975775330154</tradeName>
    <deviceName>Cervical Cell Pathology Image Analysis Software</deviceName>
    <manufacturerName>SenseCare Smart Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016662</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</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>SenseCare-TCT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:46:13.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975468130030</udiDi>
    <basicUdiDi>69754681306975468130030RS</basicUdiDi>
    <tradeName>Lower Gastrointestinal Endoscopy Real-Time Image Processing Workstation Software</tradeName>
    <deviceName>Lower Gastrointestinal Endoscopy Real-Time Image Processing Workstation Software</deviceName>
    <manufacturerName>Tianjin Yujin Artificial Intelligence Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045964</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YCWS-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:06:12.029Z</lastUpdated>
  </row>
</eudamedExport>