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<eudamedExport entity="devices">
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    <basicUdiDi>B-89041941003054</basicUdiDi>
    <tradeName>89041941003054</tradeName>
    <deviceName>Foley Balloon Catheter 2 way 18 FR (Latex)</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:25.427Z</lastUpdated>
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    <udiDi>89041941002996</udiDi>
    <basicUdiDi>B-89041941002996</basicUdiDi>
    <tradeName>89041941002996</tradeName>
    <deviceName>Foley Balloon Catheter 2 way 16 FR (Latex)</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:23.316Z</lastUpdated>
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    <udiDi>89041941002750</udiDi>
    <basicUdiDi>B-89041941002750</basicUdiDi>
    <tradeName>89041941002750</tradeName>
    <deviceName>Foley Balloon Catheter 2 way 12 FR (Latex)</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:22.267Z</lastUpdated>
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    <udiDi>89041941002514</udiDi>
    <basicUdiDi>B-89041941002514</basicUdiDi>
    <tradeName>89041941002514</tradeName>
    <deviceName>Foley Balloon Catheter 2 way  08 FR (Latex)</deviceName>
    <manufacturerName>Sterimed Group</manufacturerName>
    <manufacturerSrn>IN-MF-000032688</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMD 500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:23:22.257Z</lastUpdated>
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    <udiDi>24026704335453</udiDi>
    <basicUdiDi>B-24026704335453</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter</tradeName>
    <deviceName>PROFILCATH 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>173430-000240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:53.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>24026704335446</udiDi>
    <basicUdiDi>B-24026704335446</basicUdiDi>
    <tradeName>RUSCH Brillant Profil (Silicone) Balloon Catheter</tradeName>
    <deviceName>PROFILCATH 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>173430-000220</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:36:36.868Z</lastUpdated>
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  <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>
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  <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>
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</eudamedExport>