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<eudamedExport entity="devices">
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    <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>
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    <udiDi>06977177660853</udiDi>
    <basicUdiDi>697717766101Q5</basicUdiDi>
    <tradeName>06977177660853</tradeName>
    <deviceName>Urinary catheterization/collection kit with Prefilled Syringe</deviceName>
    <manufacturerName>ChangShu Super Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040937</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAR001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:21:32.472Z</lastUpdated>
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    <udiDi>04250098848510</udiDi>
    <basicUdiDi>04250098810032EF</basicUdiDi>
    <tradeName>UROMED PROSIL Transurethral Silicone Balloon Catheter</tradeName>
    <deviceName>TBC03</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010201</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1109.24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:39:46.224Z</lastUpdated>
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    <udiDi>89042427007542</udiDi>
    <basicUdiDi>B-89042427007542</basicUdiDi>
    <tradeName>89042427007542</tradeName>
    <deviceName>100% Silicone Foley Balloon Catheter 2-Way</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 517 BH / SMD 517</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:28.151Z</lastUpdated>
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    <udiDi>89042427007092</udiDi>
    <basicUdiDi>B-89042427007092</basicUdiDi>
    <tradeName>89042427007092</tradeName>
    <deviceName>100% Silicone Foley Balloon Catheter 2-Way</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 517 BH / SMD 517</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:27.352Z</lastUpdated>
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    <udiDi>89041941227276</udiDi>
    <basicUdiDi>B-89041941227276</basicUdiDi>
    <tradeName>89041941227276</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 24 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:23.344Z</lastUpdated>
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    <udiDi>89041941226972</udiDi>
    <basicUdiDi>B-89041941226972</basicUdiDi>
    <tradeName>89041941226972</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 22 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:22.548Z</lastUpdated>
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    <udiDi>89041941226668</udiDi>
    <basicUdiDi>B-89041941226668</basicUdiDi>
    <tradeName>89041941226668</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 20 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:21.750Z</lastUpdated>
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  <row>
    <udiDi>89041941226354</udiDi>
    <basicUdiDi>B-89041941226354</basicUdiDi>
    <tradeName>89041941226354</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 18 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:20.962Z</lastUpdated>
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  <row>
    <udiDi>89041941226040</udiDi>
    <basicUdiDi>B-89041941226040</basicUdiDi>
    <tradeName>89041941226040</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 16 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:17.338Z</lastUpdated>
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    <udiDi>89041941225746</udiDi>
    <basicUdiDi>B-89041941225746</basicUdiDi>
    <tradeName>89041941225746</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 14 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:16.144Z</lastUpdated>
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    <udiDi>89041941225432</udiDi>
    <basicUdiDi>B-89041941225432</basicUdiDi>
    <tradeName>89041941225432</tradeName>
    <deviceName>Foley Balloon Catheter 2 way - 12 FR</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>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:32:15.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>89041941030852</udiDi>
    <basicUdiDi>B-89041941030852</basicUdiDi>
    <tradeName>89041941030852</tradeName>
    <deviceName>Foley Balloon Catheter 2 way 22 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>2026-07-12T17:23:27.833Z</lastUpdated>
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    <udiDi>89041941003122</udiDi>
    <basicUdiDi>B-89041941003122</basicUdiDi>
    <tradeName>89041941003122</tradeName>
    <deviceName>Foley Balloon Catheter 2 way 20 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>2026-07-12T17:23:27.028Z</lastUpdated>
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    <udiDi>89041941003054</udiDi>
    <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>
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    <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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</eudamedExport>