<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>04026704325948</udiDi>
    <basicUdiDi>B-04026704325948</basicUdiDi>
    <tradeName>ProfilCath Preconnected Silicone Foley and Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PRECONNECTED SILICONE 2W</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851086-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:42.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704325931</udiDi>
    <basicUdiDi>B-04026704325931</basicUdiDi>
    <tradeName>ProfilCath Preconnected Silicone Foley and Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PRECONNECTED SILICONE 2W</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851086-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:41.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704325924</udiDi>
    <basicUdiDi>B-04026704325924</basicUdiDi>
    <tradeName>ProfilCath Preconnected Silicone Foley and Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PRECONNECTED SILICONE 2W</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851086-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:37.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704325917</udiDi>
    <basicUdiDi>B-04026704325917</basicUdiDi>
    <tradeName>ProfilCath Preconnected Silicone Foley and Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PRECONNECTED SILICONE 2W</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>851086-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:42:36.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704324965</udiDi>
    <basicUdiDi>B-04026704324965</basicUdiDi>
    <tradeName>3 Way Foley Coude Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUDE CH24</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664275-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:41:38.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704324958</udiDi>
    <basicUdiDi>B-04026704324958</basicUdiDi>
    <tradeName>3 Way Foley Coude Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUDE CH22</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664275-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:41:38.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704324941</udiDi>
    <basicUdiDi>B-04026704324941</basicUdiDi>
    <tradeName>3 Way Foley Coude Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUDE CH20</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664275-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:41:37.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704324934</udiDi>
    <basicUdiDi>B-04026704324934</basicUdiDi>
    <tradeName>3 Way Foley Coude Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML COUDE CH18</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664275-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:41:36.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302949</udiDi>
    <basicUdiDi>B-04026704302949</basicUdiDi>
    <tradeName>3 Way Foley Dufour Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML DUFOUR CH24</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>U010204</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664575-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:40:28.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302932</udiDi>
    <basicUdiDi>B-04026704302932</basicUdiDi>
    <tradeName>3 Way Foley Dufour Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML DUFOUR CH22</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>U010204</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664575-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:40:27.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302925</udiDi>
    <basicUdiDi>B-04026704302925</basicUdiDi>
    <tradeName>3 Way Foley Dufour Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML DUFOUR CH20</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>U010204</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664575-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:40:26.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>04026704302918</udiDi>
    <basicUdiDi>B-04026704302918</basicUdiDi>
    <tradeName>3 Way Foley Dufour Tip Catheter</tradeName>
    <deviceName>SOFTSIMPLASTIC 3W 75ML DUFOUR CH18</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>U010204</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, DUFOUR, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>664575-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:40:25.985Z</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>
</eudamedExport>