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    <tradeName>Schelin Catheter</tradeName>
    <deviceName>Schelin Catheter</deviceName>
    <manufacturerName>ProstaLund AB</manufacturerName>
    <manufacturerSrn>SE-MF-000004428</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SK812100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:02:33.970Z</lastUpdated>
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    <udiDi>24026704335415</udiDi>
    <basicUdiDi>B-24026704335415</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:30.452Z</lastUpdated>
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    <udiDi>24026704335408</udiDi>
    <basicUdiDi>B-24026704335408</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:29.646Z</lastUpdated>
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    <udiDi>24026704335392</udiDi>
    <basicUdiDi>B-24026704335392</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT 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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:25.644Z</lastUpdated>
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  <row>
    <udiDi>24026704335385</udiDi>
    <basicUdiDi>B-24026704335385</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT 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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:24.844Z</lastUpdated>
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  <row>
    <udiDi>24026704335378</udiDi>
    <basicUdiDi>B-24026704335378</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT 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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:24.130Z</lastUpdated>
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    <udiDi>24026704335361</udiDi>
    <basicUdiDi>B-24026704335361</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT 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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:22.454Z</lastUpdated>
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    <udiDi>24026704335354</udiDi>
    <basicUdiDi>B-24026704335354</basicUdiDi>
    <tradeName>RUSCH Brillant (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT 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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>170605-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:18.459Z</lastUpdated>
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    <udiDi>24026704335255</udiDi>
    <basicUdiDi>B-24026704335255</basicUdiDi>
    <tradeName>RUSCH Brillant Profil Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT PROFIL SILICONE 2W 10ML TI</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171365-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:04.838Z</lastUpdated>
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  <row>
    <udiDi>24026704335248</udiDi>
    <basicUdiDi>B-24026704335248</basicUdiDi>
    <tradeName>RUSCH Brillant Profil Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT PROFIL SILICONE 2W 10ML TI</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171365-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:04.035Z</lastUpdated>
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    <udiDi>24026704335231</udiDi>
    <basicUdiDi>B-24026704335231</basicUdiDi>
    <tradeName>RUSCH Brillant Profil Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT PROFIL SILICONE 2W 10ML TI</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171365-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:03.237Z</lastUpdated>
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  <row>
    <udiDi>24026704335224</udiDi>
    <basicUdiDi>B-24026704335224</basicUdiDi>
    <tradeName>RUSCH Brillant Profil Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT PROFIL SILICONE 2W 10ML TI</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171365-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:02.528Z</lastUpdated>
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  <row>
    <udiDi>24026704335217</udiDi>
    <basicUdiDi>B-24026704335217</basicUdiDi>
    <tradeName>RUSCH Brillant Profil Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT PROFIL SILICONE 2W 10ML TI</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171365-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:57.636Z</lastUpdated>
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    <udiDi>24026704335200</udiDi>
    <basicUdiDi>B-24026704335200</basicUdiDi>
    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</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>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:56.853Z</lastUpdated>
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    <udiDi>24026704335194</udiDi>
    <basicUdiDi>B-24026704335194</basicUdiDi>
    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:56.031Z</lastUpdated>
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    <udiDi>24026704335187</udiDi>
    <basicUdiDi>B-24026704335187</basicUdiDi>
    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010206</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:55.231Z</lastUpdated>
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    <udiDi>24026704335170</udiDi>
    <basicUdiDi>B-24026704335170</basicUdiDi>
    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000180</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:50.434Z</lastUpdated>
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    <udiDi>24026704335163</udiDi>
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    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000024692</manufacturerSrn>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:49.703Z</lastUpdated>
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    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000140</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:33.571Z</lastUpdated>
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    <tradeName>RUSCH Brillant Tiemann (Silicone) Balloon Catheter</tradeName>
    <deviceName>BRILLANT SILICONE 2W 10ML TIEMANN</deviceName>
    <manufacturerName>Teleflex Medical Sdn. Bhd.</manufacturerName>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, TIEMANN WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171305-000120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:35:32.767Z</lastUpdated>
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