<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04560333350174</udiDi>
    <basicUdiDi>4560333350001U9</basicUdiDi>
    <tradeName>Proton Therapy System</tradeName>
    <deviceName>PROBEAT-LL</deviceName>
    <manufacturerName>Hitachi High-Tech Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000016991</manufacturerSrn>
    <authorisedRepresentativeName>Hitachi Europe S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018988</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11011001</emdnCode>
    <emdnDescription>PROTON THERAPY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROBEAT-LL</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T18:29:23.299Z</lastUpdated>
  </row>
</eudamedExport>