<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818053022579</udiDi>
    <basicUdiDi>B-00818053022579</basicUdiDi>
    <tradeName>XCEL Detachment Controller</tradeName>
    <deviceName>XCEL Detachment Controller</deviceName>
    <manufacturerName>BALT USA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008651</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCEL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:18:05.949Z</lastUpdated>
  </row>
</eudamedExport>