<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813307010845</udiDi>
    <basicUdiDi>B-00813307010845</basicUdiDi>
    <tradeName>Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm</tradeName>
    <deviceName>Blom-Singer® Advantage Indwelling 20 Fr. (Hard Valve) Voice Prosthesis, 4mm</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0204</emdnCode>
    <emdnDescription>LARYNX PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD 2004-NS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:17.949Z</lastUpdated>
  </row>
</eudamedExport>