<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04026704441815</udiDi>
    <basicUdiDi>B-04026704441815</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 30ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5736-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:43:00.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441808</udiDi>
    <basicUdiDi>B-04026704441808</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 30ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5736-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:43:00.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441792</udiDi>
    <basicUdiDi>B-04026704441792</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 30ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5736-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:58.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441785</udiDi>
    <basicUdiDi>B-04026704441785</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 30ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5736-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:56.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441778</udiDi>
    <basicUdiDi>B-04026704441778</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 30ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5736-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:54.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441761</udiDi>
    <basicUdiDi>B-04026704441761</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 75ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5738-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:53.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441754</udiDi>
    <basicUdiDi>B-04026704441754</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 75ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5738-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:52.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441747</udiDi>
    <basicUdiDi>B-04026704441747</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 75ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5738-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:49.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704441730</udiDi>
    <basicUdiDi>B-04026704441730</basicUdiDi>
    <tradeName>3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMP PLUS 3W 75ML COUVELAIRE CH</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRGB5738-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:47.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302901</udiDi>
    <basicUdiDi>B-04026704302901</basicUdiDi>
    <tradeName>SoftSimplastic 3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664176-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:38:59.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302895</udiDi>
    <basicUdiDi>B-04026704302895</basicUdiDi>
    <tradeName>SoftSimplastic 3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664176-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:38:59.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302888</udiDi>
    <basicUdiDi>B-04026704302888</basicUdiDi>
    <tradeName>SoftSimplastic 3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664176-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:38:58.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302871</udiDi>
    <basicUdiDi>B-04026704302871</basicUdiDi>
    <tradeName>SoftSimplastic 3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664176-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:38:57.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302611</udiDi>
    <basicUdiDi>B-04026704302611</basicUdiDi>
    <tradeName>SoftSimplastic 3 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664130-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:38:53.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069774</udiDi>
    <basicUdiDi>B-04026704069774</basicUdiDi>
    <tradeName>2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662575-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:54.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069767</udiDi>
    <basicUdiDi>B-04026704069767</basicUdiDi>
    <tradeName>2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662575-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:50.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069750</udiDi>
    <basicUdiDi>B-04026704069750</basicUdiDi>
    <tradeName>2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662575-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:49.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069743</udiDi>
    <basicUdiDi>B-04026704069743</basicUdiDi>
    <tradeName>2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 75ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662575-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:48.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069736</udiDi>
    <basicUdiDi>B-04026704069736</basicUdiDi>
    <tradeName>SoftSimplastic 2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662530-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:47.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704069729</udiDi>
    <basicUdiDi>B-04026704069729</basicUdiDi>
    <tradeName>SoftSimplastic 2 Way Foley Couvelaire Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 2W 30ML COUVELAIRE C</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010202</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>662530-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:37:43.024Z</lastUpdated>
  </row>
</eudamedExport>