<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800018600450</udiDi>
    <basicUdiDi>B-08800018600450</basicUdiDi>
    <tradeName>HDI-S</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-714</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:45.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600443</udiDi>
    <basicUdiDi>B-08800018600443</basicUdiDi>
    <tradeName>HDI-P</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-714</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:44.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600436</udiDi>
    <basicUdiDi>B-08800018600436</basicUdiDi>
    <tradeName>HDI-P</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-714</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:44.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600221</udiDi>
    <basicUdiDi>B-08800018600221</basicUdiDi>
    <tradeName>EzSensor HD</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-712</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:40.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600214</udiDi>
    <basicUdiDi>B-08800018600214</basicUdiDi>
    <tradeName>EzSensor HD</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-712</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:39.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600207</udiDi>
    <basicUdiDi>B-08800018600207</basicUdiDi>
    <tradeName>EzSensor HD</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-712</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:38.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600191</udiDi>
    <basicUdiDi>B-08800018600191</basicUdiDi>
    <tradeName>EzSensor Classic</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-711</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:37.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600184</udiDi>
    <basicUdiDi>B-08800018600184</basicUdiDi>
    <tradeName>EzSensor Classic</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-711</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:32.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800018600177</udiDi>
    <basicUdiDi>B-08800018600177</basicUdiDi>
    <tradeName>EzSensor Classic</tradeName>
    <deviceName>Medical Image Processing Unit (Intra Oral Imaging System)</deviceName>
    <manufacturerName>Rayence Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000014713</manufacturerSrn>
    <authorisedRepresentativeName>VATECH GLOBAL FRANCE SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000009694</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-USM-711</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:01:31.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899581334023</udiDi>
    <basicUdiDi>B-07899581334023</basicUdiDi>
    <tradeName>Intraoral dental digital imaging sensor</tradeName>
    <deviceName>Intraoral dental digital imaging sensor</deviceName>
    <manufacturerName>ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA</manufacturerName>
    <manufacturerSrn>BR-MF-000016681</manufacturerSrn>
    <authorisedRepresentativeName>ELS SOLUTIONS GDIA - UNIPESSOAL LDA.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000026128</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16000002943</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:57:02.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899581333972</udiDi>
    <basicUdiDi>B-07899581333972</basicUdiDi>
    <tradeName>Intraoral dental digital imaging sensor</tradeName>
    <deviceName>Intraoral dental digital imaging sensor</deviceName>
    <manufacturerName>ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA</manufacturerName>
    <manufacturerSrn>BR-MF-000016681</manufacturerSrn>
    <authorisedRepresentativeName>ELS SOLUTIONS GDIA - UNIPESSOAL LDA.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000026128</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16000002940</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:57:01.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899581323690</udiDi>
    <basicUdiDi>B-07899581323690</basicUdiDi>
    <tradeName>Intraoral dental digital imaging sensor</tradeName>
    <deviceName>Intraoral dental digital imaging sensor</deviceName>
    <manufacturerName>ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA</manufacturerName>
    <manufacturerSrn>BR-MF-000016681</manufacturerSrn>
    <authorisedRepresentativeName>ELS SOLUTIONS GDIA - UNIPESSOAL LDA.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000026128</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16000000589</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:57:00.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899581323645</udiDi>
    <basicUdiDi>B-07899581323645</basicUdiDi>
    <tradeName>Intraoral dental digital imaging sensor</tradeName>
    <deviceName>Intraoral dental digital imaging sensor</deviceName>
    <manufacturerName>ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA</manufacturerName>
    <manufacturerSrn>BR-MF-000016681</manufacturerSrn>
    <authorisedRepresentativeName>ELS SOLUTIONS GDIA - UNIPESSOAL LDA.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000026128</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16000000583</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:56:56.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566272048</udiDi>
    <basicUdiDi>B-06974566272048</basicUdiDi>
    <tradeName>FUSSEN</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F100 size#2</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:08.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566272031</udiDi>
    <basicUdiDi>B-06974566272031</basicUdiDi>
    <tradeName>FUSSEN</tradeName>
    <deviceName>Digital Intraoral X-ray Imaging 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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F100 size#1</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:51:07.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899581345197</udiDi>
    <basicUdiDi>78995813ScannerAXRSUP</basicUdiDi>
    <tradeName>Intraoral Scanner</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA</manufacturerName>
    <manufacturerSrn>BR-MF-000016681</manufacturerSrn>
    <authorisedRepresentativeName>ELS SOLUTIONS GDIA - UNIPESSOAL LDA.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000026128</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16000004759</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:14:56.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979991590019</udiDi>
    <basicUdiDi>697999159IOS00155</basicUdiDi>
    <tradeName>06979991590019</tradeName>
    <deviceName>intra oral scanner</deviceName>
    <manufacturerName>SUZHOU ESCO MEDICAL EQUIPMENT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000052833</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:57:45.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979047810009</udiDi>
    <basicUdiDi>697904781Axt1ZH</basicUdiDi>
    <tradeName>Intraoral Scanner</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>Guangzhou Axcede Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000049452</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06979047810009</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:23:07.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978981675002</udiDi>
    <basicUdiDi>69789816736610BLF163A</basicUdiDi>
    <tradeName>Intraoral Digital Impression Instrument</tradeName>
    <deviceName>Intraoral Digital Impression Instrument</deviceName>
    <manufacturerName>Sichuan BELIEF Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049809</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLF-S500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:18:21.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978406190004</udiDi>
    <basicUdiDi>697840619C32R</basicUdiDi>
    <tradeName>06978406190004</tradeName>
    <deviceName>Intraoral Scanner</deviceName>
    <manufacturerName>Hangzhou Tzin TECH CO;LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048065</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11030402</emdnCode>
    <emdnDescription>SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:32:35.801Z</lastUpdated>
  </row>
</eudamedExport>