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    <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>1108.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:04.660Z</lastUpdated>
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  <row>
    <udiDi>04250098821391</udiDi>
    <basicUdiDi>04250098810033EH</basicUdiDi>
    <tradeName>UROMED PROSIL Transurethral Silicone Balloon Catheter for Children</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>1350.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:58.489Z</lastUpdated>
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  <row>
    <udiDi>04250098801270</udiDi>
    <basicUdiDi>04250098810031ED</basicUdiDi>
    <tradeName>UROMED Transurethral Silicone Balloon Catheter for Children</tradeName>
    <deviceName>TBC01</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>1340.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:19.262Z</lastUpdated>
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  <row>
    <udiDi>04250098800679</udiDi>
    <basicUdiDi>04250098810035EM</basicUdiDi>
    <tradeName>UROMED SILUCENT Transurethral Silicone Balloon Catheter</tradeName>
    <deviceName>TBC02</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>1104.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:18.466Z</lastUpdated>
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  <row>
    <udiDi>04250098800136</udiDi>
    <basicUdiDi>04250098810034EK</basicUdiDi>
    <tradeName>UROMED Transurethral Silicone Balloon Catheter »soft«</tradeName>
    <deviceName>TBC02</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>1095.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:17.663Z</lastUpdated>
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  <row>
    <udiDi>04250098800013</udiDi>
    <basicUdiDi>04250098810030EB</basicUdiDi>
    <tradeName>UROMED Transurethral Silicone Balloon Catheter</tradeName>
    <deviceName>TBC01</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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090.16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:16.873Z</lastUpdated>
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  <row>
    <udiDi>05907996868292</udiDi>
    <basicUdiDi>B-05907996868292</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with plastic valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-10-05-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:34.991Z</lastUpdated>
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  <row>
    <udiDi>05907996868261</udiDi>
    <basicUdiDi>B-05907996868261</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with plastic valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-08-05-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:32.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996868230</udiDi>
    <basicUdiDi>B-05907996868230</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with plastic valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-06-03-P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:30.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996839094</udiDi>
    <basicUdiDi>B-05907996839094</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-26-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:19.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996839063</udiDi>
    <basicUdiDi>B-05907996839063</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-24-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:18.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996839032</udiDi>
    <basicUdiDi>B-05907996839032</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-22-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:17.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996839001</udiDi>
    <basicUdiDi>B-05907996839001</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-20-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:15.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838882</udiDi>
    <basicUdiDi>B-05907996838882</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-24-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:13.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838820</udiDi>
    <basicUdiDi>B-05907996838820</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-20-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:11.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838912</udiDi>
    <basicUdiDi>B-05907996838912</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-26-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:10.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838851</udiDi>
    <basicUdiDi>B-05907996838851</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-22-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:29:08.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838974</udiDi>
    <basicUdiDi>B-05907996838974</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-18-30-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:51.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838769</udiDi>
    <basicUdiDi>B-05907996838769</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-16-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:49.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996838738</udiDi>
    <basicUdiDi>B-05907996838738</basicUdiDi>
    <tradeName>TWO-WAY FOLEY CATHETER with rubber valve</tradeName>
    <deviceName>sterile Foley catheter</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CFNL-2D-14-10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:55:47.092Z</lastUpdated>
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