<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08885022330005</udiDi>
    <basicUdiDi>888502233EnFocusM8</basicUdiDi>
    <tradeName>EnFocus 2300 Integrated OCT System</tradeName>
    <deviceName>EnFocus 2300 Integrated OCT System</deviceName>
    <manufacturerName>Leica Instruments (Singapore) Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000050256</manufacturerSrn>
    <authorisedRepresentativeName>Leica Microsystems CMS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000021052</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120121</emdnCode>
    <emdnDescription>OPTICAL CONSISTENCY TOMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900C23550V5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:51:43.978Z</lastUpdated>
  </row>
</eudamedExport>