<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800018600436</udiDi>
    <basicUdiDi>88000186IOSU10VFYD</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>HDI-U10DF</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:52:36.475Z</lastUpdated>
  </row>
</eudamedExport>