<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>24026704335439</udiDi>
    <basicUdiDi>B-24026704335439</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 20ML</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>173430-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:32.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335422</udiDi>
    <basicUdiDi>B-24026704335422</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter</tradeName>
    <deviceName>PROFILCATH SILICONE 3W 20ML</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>173430-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:31.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335347</udiDi>
    <basicUdiDi>B-24026704335347</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:17.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335330</udiDi>
    <basicUdiDi>B-24026704335330</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:16.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335323</udiDi>
    <basicUdiDi>B-24026704335323</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:16.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335316</udiDi>
    <basicUdiDi>B-24026704335316</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:11.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335309</udiDi>
    <basicUdiDi>B-24026704335309</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:10.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335293</udiDi>
    <basicUdiDi>B-24026704335293</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:09.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335286</udiDi>
    <basicUdiDi>B-24026704335286</basicUdiDi>
    <tradeName>RUSCH Brillant ProfilCath AquaFlate Glycerine (100% Silicone) Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>PROFILCATH GLYCERIN SILICONE 2W 10M</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>171505-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:08.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335118</udiDi>
    <basicUdiDi>B-24026704335118</basicUdiDi>
    <tradeName>RUSCH Brillant Paediatric (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 5ML PAED.</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>170003-000100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:26.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335101</udiDi>
    <basicUdiDi>B-24026704335101</basicUdiDi>
    <tradeName>RUSCH Brillant Paediatric (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 3ML PAED.</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>170003-000080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:25.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335095</udiDi>
    <basicUdiDi>B-24026704335095</basicUdiDi>
    <tradeName>RUSCH Brillant Paediatric (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 1.5ML PAED.</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>170003-000060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:24.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334937</udiDi>
    <basicUdiDi>B-24026704334937</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 30ML</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>170630-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:23.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334920</udiDi>
    <basicUdiDi>B-24026704334920</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 30ML</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>170630-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:20.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334913</udiDi>
    <basicUdiDi>B-24026704334913</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 20ML</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>170630-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:18.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334906</udiDi>
    <basicUdiDi>B-24026704334906</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 20ML</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>170630-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:17.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334845</udiDi>
    <basicUdiDi>B-24026704334845</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 3W 30ML</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>173830-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:16.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334838</udiDi>
    <basicUdiDi>B-24026704334838</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 3W 30ML</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>173830-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:11.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334821</udiDi>
    <basicUdiDi>B-24026704334821</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 3W 20ML</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>173830-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:11.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704334814</udiDi>
    <basicUdiDi>B-24026704334814</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 3W 20ML</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>173830-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:10.361Z</lastUpdated>
  </row>
</eudamedExport>