<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07332747199079</udiDi>
    <basicUdiDi>733274700000016275</basicUdiDi>
    <tradeName>IPS CaseDesigner 2.5 for MAC</tradeName>
    <deviceName></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_V2.5_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:19.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747199512</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.2 for Win 64-bit</tradeName>
    <deviceName></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>300851_V3.2_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:19.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747199529</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.2 for Mac</tradeName>
    <deviceName></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>300851_V3.2_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:19.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747199772</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.3 for Mac</tradeName>
    <deviceName></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>300851_V3.3_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:18.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747199789</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.3 for Win 64-bit</tradeName>
    <deviceName></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>300851_V3.3_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:18.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747200577</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.4 for Mac</tradeName>
    <deviceName></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>300851_V3.4_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:18.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747200584</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 3.4 for Win 64-bit</tradeName>
    <deviceName></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>300851_V3.4_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:18.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747202861</udiDi>
    <basicUdiDi>733274700000016275</basicUdiDi>
    <tradeName>IPS CaseDesigner 2.6 for Windows 64-bit</tradeName>
    <deviceName></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_V2.6_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:17.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747202878</udiDi>
    <basicUdiDi>733274700000016275</basicUdiDi>
    <tradeName>IPS CaseDesigner 2.6 for MAC</tradeName>
    <deviceName></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_V2.6_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:32:17.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747215212</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.3 for Win 64-bit</tradeName>
    <deviceName></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>300851_V4.3_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:28.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747215229</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.3 for Mac</tradeName>
    <deviceName></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>300851_V4.3_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:28.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747219616</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.4 for Win 64-bit</tradeName>
    <deviceName></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>300851_V4.4_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:16.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747219623</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.4 for Mac</tradeName>
    <deviceName></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>300851_V4.4_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:16.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747221183</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.5 for Win 64-bit</tradeName>
    <deviceName></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>300851_V4.5_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:15.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747221190</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.5 for Mac</tradeName>
    <deviceName></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>300851_V4.5_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:15.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747236620</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.8 for Win 64-bit</tradeName>
    <deviceName></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>300851_V4.8_WIN64</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:11.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332747236637</udiDi>
    <basicUdiDi>73327470000002206S</basicUdiDi>
    <tradeName>DTX Studio Clinic 4.8 for Mac</tradeName>
    <deviceName></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>300851_V4.8_MAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:11.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>B865VEYECLINIC0101X0</udiDi>
    <basicUdiDi>++B865VeyeClinicLJ</basicUdiDi>
    <tradeName>Veye Clinic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidence B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000534</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>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:26:16.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>B865VEYECLINIC0102X0</udiDi>
    <basicUdiDi>++B865VeyeClinicLJ</basicUdiDi>
    <tradeName>Veye Clinic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidence B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000534</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>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:26:16.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>B865VEYECLINIC0103X0</udiDi>
    <basicUdiDi>++B865VeyeClinicLJ</basicUdiDi>
    <tradeName>Veye Clinic</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidence B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000534</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>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:26:16.746Z</lastUpdated>
  </row>
</eudamedExport>