<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00628055858010</udiDi>
    <basicUdiDi>62805585801SF</basicUdiDi>
    <tradeName>00628055858010</tradeName>
    <deviceName>Fusion Bx</deviceName>
    <manufacturerName>Focal Healthcare Inc</manufacturerName>
    <manufacturerSrn>CA-MF-000050812</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.0</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:30:53.980Z</lastUpdated>
  </row>
</eudamedExport>