<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05744005970009</udiDi>
    <basicUdiDi>574400597TheViewerKF</basicUdiDi>
    <tradeName>Copenhagen Imaging, The Viewer Software</tradeName>
    <deviceName>The Viewer Software</deviceName>
    <manufacturerName>Copenhagen Imaging ApS</manufacturerName>
    <manufacturerSrn>DK-MF-000001219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030392</emdnCode>
    <emdnDescription>INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.0.4</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:39:01.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>04548213030798</udiDi>
    <basicUdiDi>4548213000B0017E4</basicUdiDi>
    <tradeName>Veraview X800</tradeName>
    <deviceName>Veraview X800</deviceName>
    <manufacturerName>J. MORITA MFG. CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000023000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:56:15.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190000000X</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughMAX XRE-100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:15:36.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190000010Y</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughMAX XRE-100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:26.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190000030-</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughMAX XRE-100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:26.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190000040.</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughMAX XRE-100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:26.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190000050</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughMAX XRE-100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19000005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:25.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100000Y</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:25.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100010Z</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:25.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100030.</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:11.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100040</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:51:07.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100050$</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:50:43.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190100060/</udiDi>
    <basicUdiDi>++E30861019G7</basicUdiDi>
    <tradeName>seethroughFLEX XRE-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19010006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:50:17.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566270136</udiDi>
    <basicUdiDi>697456627RubikX3BH</basicUdiDi>
    <tradeName>Rubix X1</tradeName>
    <deviceName>Dental Computed Tomography X-ray System</deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Matrix 7000 Configuration 1 (CEPH)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:54:20.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566271126</udiDi>
    <basicUdiDi>697456627RubikX3BH</basicUdiDi>
    <tradeName>Rubix X1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Matrix 7000 configuration 1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:17.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566271287</udiDi>
    <basicUdiDi>697456627RubikX3BH</basicUdiDi>
    <tradeName>Rubix X3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Matrix 7800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:12.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566270143</udiDi>
    <basicUdiDi>697456627RubikX3BH</basicUdiDi>
    <tradeName>Rubix X3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Matrix 7800 (CEPH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:12.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566270150</udiDi>
    <basicUdiDi>697456627RubikX3BH</basicUdiDi>
    <tradeName>Rubix X3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fussen Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009373</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1103030102</emdnCode>
    <emdnDescription>EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Matrix 7800 (CEPH-ONE SHOT)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:46:11.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>+E308190600000$</udiDi>
    <basicUdiDi>++E30860883HH</basicUdiDi>
    <tradeName>seethrough studio DID-200</tradeName>
    <deviceName></deviceName>
    <manufacturerName>W&amp;H Sterilization Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000008237</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030392</emdnCode>
    <emdnDescription>INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19060000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:43:56.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860010893203</udiDi>
    <basicUdiDi>086001089321.0FT</basicUdiDi>
    <tradeName>00860010893203</tradeName>
    <deviceName>VELMENI for DENTISTS(V4D)</deviceName>
    <manufacturerName>VELMENI Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000046518</manufacturerSrn>
    <authorisedRepresentativeName>Freyr Life Sciences GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000021795</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030392</emdnCode>
    <emdnDescription>INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V4D1.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:36.266Z</lastUpdated>
  </row>
</eudamedExport>