<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00864366000124</udiDi>
    <basicUdiDi>B-00864366000124</basicUdiDi>
    <tradeName>Mevion S250i</tradeName>
    <deviceName>Mevion S250i</deviceName>
    <manufacturerName>Mevion Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008692</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11011001</emdnCode>
    <emdnDescription>PROTON THERAPY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S250i</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:07.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00864366000117</udiDi>
    <basicUdiDi>08643660001S250L2</basicUdiDi>
    <tradeName>MEVION S250-FIT Proton Therapy System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mevion Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008692</manufacturerSrn>
    <authorisedRepresentativeName>Regulatory Quality Management Information Source AREU, S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000002139</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTON THERAPY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S250-FIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:24.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00864366000148</udiDi>
    <basicUdiDi>08643660001S250L2</basicUdiDi>
    <tradeName>MEVION S250-FIT Proton Therapy System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mevion Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008692</manufacturerSrn>
    <authorisedRepresentativeName>Regulatory Quality Management Information Source AREU, S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000002139</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROTON THERAPY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S250-FIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:15:24.562Z</lastUpdated>
  </row>
</eudamedExport>