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    <tradeName>Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>BRILLANT AQUAFLATE SILICONE 2W 10ML</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>178000-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:59.859Z</lastUpdated>
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    <udiDi>24026704320640</udiDi>
    <basicUdiDi>B-24026704320640</basicUdiDi>
    <tradeName>Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>BRILLANT AQUAFLATE SILICONE 2W 10ML</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>178000-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:59.052Z</lastUpdated>
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    <udiDi>24026704320633</udiDi>
    <basicUdiDi>B-24026704320633</basicUdiDi>
    <tradeName>Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>BRILLANT AQUAFLATE SILICONE 2W 10ML</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>178000-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:58.254Z</lastUpdated>
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    <udiDi>24026704320626</udiDi>
    <basicUdiDi>B-24026704320626</basicUdiDi>
    <tradeName>Rusch Brillant AquaFlate Glycerine Silicone Balloon Catheter with Pre-filled Syringe</tradeName>
    <deviceName>BRILLANT AQUAFLATE SILICONE 2W 10ML</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>178000-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:57.448Z</lastUpdated>
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    <udiDi>24026704111408</udiDi>
    <basicUdiDi>B-24026704111408</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:18.983Z</lastUpdated>
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    <udiDi>24026704106435</udiDi>
    <basicUdiDi>B-24026704106435</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:14.977Z</lastUpdated>
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    <udiDi>24026704105155</udiDi>
    <basicUdiDi>B-24026704105155</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:33:14.181Z</lastUpdated>
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    <udiDi>24026704098563</udiDi>
    <basicUdiDi>B-24026704098563</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:19.599Z</lastUpdated>
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    <udiDi>24026704098556</udiDi>
    <basicUdiDi>B-24026704098556</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:18.799Z</lastUpdated>
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    <udiDi>24026704098549</udiDi>
    <basicUdiDi>B-24026704098549</basicUdiDi>
    <tradeName>Preconnected Drainage System with Silicone Catheter and Silflate</tradeName>
    <deviceName>BRLILLANT PRECONNECT SILICONE 10ML</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>171100-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:18.000Z</lastUpdated>
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    <udiDi>24026704080810</udiDi>
    <basicUdiDi>B-24026704080810</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:17.206Z</lastUpdated>
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    <udiDi>24026704079913</udiDi>
    <basicUdiDi>B-24026704079913</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:13.197Z</lastUpdated>
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    <udiDi>24026704079906</udiDi>
    <basicUdiDi>B-24026704079906</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:12.645Z</lastUpdated>
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    <udiDi>24026704079890</udiDi>
    <basicUdiDi>B-24026704079890</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:11.599Z</lastUpdated>
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    <udiDi>24026704079883</udiDi>
    <basicUdiDi>B-24026704079883</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:10.816Z</lastUpdated>
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    <udiDi>24026704079876</udiDi>
    <basicUdiDi>B-24026704079876</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:06.796Z</lastUpdated>
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    <udiDi>24026704079869</udiDi>
    <basicUdiDi>B-24026704079869</basicUdiDi>
    <tradeName>Profilcath Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>PROFILCATH PLUS SILICONE 2W 10ML</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>850088-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:05.994Z</lastUpdated>
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    <udiDi>24026704079845</udiDi>
    <basicUdiDi>B-24026704079845</basicUdiDi>
    <tradeName>Brillant Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>BRILLANT PLUS AQUAFLATE 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>850085-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:05.197Z</lastUpdated>
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    <udiDi>24026704079838</udiDi>
    <basicUdiDi>B-24026704079838</basicUdiDi>
    <tradeName>Brillant Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>BRILLANT PLUS AQUAFLATE 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>850085-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:04.392Z</lastUpdated>
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    <udiDi>24026704079821</udiDi>
    <basicUdiDi>B-24026704079821</basicUdiDi>
    <tradeName>Brillant Plus Aquaflate Silicone Balloon Catheter with Prefilled Syringe</tradeName>
    <deviceName>BRILLANT PLUS AQUAFLATE 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>850085-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:31:00.387Z</lastUpdated>
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