<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10814932020244</udiDi>
    <basicUdiDi>08019020000000000000027KC</basicUdiDi>
    <tradeName>Urolift System</tradeName>
    <deviceName>UroLift System</deviceName>
    <manufacturerName>Neotract, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000050907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P08030101</emdnCode>
    <emdnDescription>TRANS-PROSTATIC URETHRAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UL400-4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:23:53.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850004725047</udiDi>
    <basicUdiDi>B-00850004725047</basicUdiDi>
    <tradeName>Deflux Gel for Injection</tradeName>
    <deviceName>DEFLUX SYRINGE (1ML)</deviceName>
    <manufacturerName>Palette Life Sciences Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014009</manufacturerSrn>
    <authorisedRepresentativeName>Scandinavian Regulatory Services AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000004526</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080302</emdnCode>
    <emdnDescription>URETERAL PROSTHESES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>011503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:51:23.133Z</lastUpdated>
  </row>
</eudamedExport>