<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800099500083</udiDi>
    <basicUdiDi>B-08800099500083</basicUdiDi>
    <tradeName>PEDRA-1417MC</tradeName>
    <deviceName>DIGITAL FLAT PANEL DETECTOR</deviceName>
    <manufacturerName>Radisen Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000011625</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEDRA-1417MC</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:05.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099500076</udiDi>
    <basicUdiDi>B-08800099500076</basicUdiDi>
    <tradeName>AXIR-CX</tradeName>
    <deviceName>Computer Aided Detection Software</deviceName>
    <manufacturerName>Radisen Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000011625</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11030582</emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Attachment 01_AXIR-CX_Catalog_rev.1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:04.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800099500052</udiDi>
    <basicUdiDi>B-08800099500052</basicUdiDi>
    <tradeName>PEDRA-17F</tradeName>
    <deviceName>Digital Flat Panel X-Ray Detector</deviceName>
    <manufacturerName>Radisen Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000011625</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11031180</emdnCode>
    <emdnDescription>SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS-AD-170912-01</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:48:04.097Z</lastUpdated>
  </row>
</eudamedExport>