<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00848253000947</udiDi>
    <basicUdiDi>B-00848253000947</basicUdiDi>
    <tradeName>Adjustable Bi-Flanged Fistula Prosthesis - 25mm</tradeName>
    <deviceName>Adjustable Bi-Flanged Fistula Prosthesis - 25mm</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0299</emdnCode>
    <emdnDescription>ENT PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-1003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T15:09:38.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848253000954</udiDi>
    <basicUdiDi>B-00848253000954</basicUdiDi>
    <tradeName>Adjustable Bi-Flanged Fistula Prosthesis - 38mm</tradeName>
    <deviceName>Adjustable Bi-Flanged Fistula Prosthesis - 38mm</deviceName>
    <manufacturerName>Freudenberg Medical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023823</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0299</emdnCode>
    <emdnDescription>ENT PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FM-1004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:34:15.090Z</lastUpdated>
  </row>
</eudamedExport>