<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>10850011472122</udiDi>
    <basicUdiDi>008500114724000238CKT</basicUdiDi>
    <tradeName>Pro-Tx Endorectal Balloon</tradeName>
    <deviceName>Pro-Tx Endorectal Balloon</deviceName>
    <manufacturerName>DxTx Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026795</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11010485</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PROT-25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:53.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989403904910</udiDi>
    <basicUdiDi>B-86989403904910</basicUdiDi>
    <tradeName>Bolus Materyali</tradeName>
    <deviceName>Gel Bolus</deviceName>
    <manufacturerName>RADON TIBBİ MALZEMELER İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000018717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11010485</emdnCode>
    <emdnDescription>RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBL000051</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:24:09.166Z</lastUpdated>
  </row>
</eudamedExport>