<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05701780761574</udiDi>
    <basicUdiDi>57089322978179D</basicUdiDi>
    <tradeName>EasiCath Dilatation</tradeName>
    <deviceName>EasiCath Dilatation urinary intermittent dilatation catheter</deviceName>
    <manufacturerName>Coloplast A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000025526</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>28318</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:11.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849234</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName>UAS01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4045.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:26.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098804844</udiDi>
    <basicUdiDi>04250098810036EP</basicUdiDi>
    <tradeName>UROMED Fascial Dilator with Peel Away Sheath</tradeName>
    <deviceName>FD01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2655.15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:42.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098804608</udiDi>
    <basicUdiDi>04250098810027EN</basicUdiDi>
    <tradeName>UROMED Fascial Dilator</tradeName>
    <deviceName>FD01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2650.07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:37:40.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849210</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName>UAS01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4035.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:34:25.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098804875</udiDi>
    <basicUdiDi>04250098810028EQ</basicUdiDi>
    <tradeName>UROMED Fascial Dilation Set</tradeName>
    <deviceName>FD01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2656</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:32.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098804813</udiDi>
    <basicUdiDi>04250098810036EP</basicUdiDi>
    <tradeName>UROMED Fascial Dilator with Peel Away Sheath</tradeName>
    <deviceName>FD01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2655.13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:32.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098804578</udiDi>
    <basicUdiDi>04250098810027EN</basicUdiDi>
    <tradeName>UROMED Fascial Dilator</tradeName>
    <deviceName>FD01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2650.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:33:31.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002180017</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set; Amplatz Renal Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-240016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:20.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002179646</udiDi>
    <basicUdiDi>0827002CINC050-123_A5YR</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Radiopaque TFE Sheath Use with Amplatz Dilator</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-240016-ARI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:51:16.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002180130</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-180016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:35.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002180048</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-300016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:34.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002180161</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARI-300025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:34.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002179844</udiDi>
    <basicUdiDi>0827002CINC050-123_A5YR</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-180016-ARI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:30.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002179769</udiDi>
    <basicUdiDi>0827002CINC050-123_A5YR</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-300030-ARI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:47:28.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002460300</udiDi>
    <basicUdiDi>0827002CINC050-123_A3YM</basicUdiDi>
    <tradeName>00827002460300</tradeName>
    <deviceName>Clear Amplatz Sheath With Radiopaque Stripe</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAS-180017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:36.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002303584</udiDi>
    <basicUdiDi>0827002CINC050-123_A2YK</basicUdiDi>
    <tradeName>Ultraxx™</tradeName>
    <deviceName>Ultraxx™ Nephrostomy Balloon [With TFE Sheath: Clear Amplatz Sheath With Radiopaque Stripe]</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNB-10-15-CS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:36.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002173224</udiDi>
    <basicUdiDi>0827002CINC050-123_A1YH</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set With AQ® Hydrophilic Coating</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-075000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:35.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002143050</udiDi>
    <basicUdiDi>0827002CINC050-123_A4YP</basicUdiDi>
    <tradeName>00827002143050</tradeName>
    <deviceName>Catheter For Use With Amplatz Renal Dilator Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:34.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002142923</udiDi>
    <basicUdiDi>0827002CINC050-123_AJ3</basicUdiDi>
    <tradeName>Amplatz</tradeName>
    <deviceName>Amplatz Renal Dilator Set; Amplatz Renal Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>075000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:29.743Z</lastUpdated>
  </row>
</eudamedExport>