<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00819374021203</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &amp; Sets, GLIDER Amplatz Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-AM16/30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.278Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021227</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>GLIDER Amplatz Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021999</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &amp; Sets, GLIDER Amplatz Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-AM22/30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374023931</udiDi>
    <basicUdiDi>081226101DST010RV</basicUdiDi>
    <tradeName>ARMADA Dilators &amp; Sets, GLIDER Amplatz Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-AM20/30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002176362</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Ureteral Dilator With AQ® Hydrophilic Coating With Modified Taper</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQ-076012-TP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:03:50.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002327894</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator Set with AQ® Hydrophilic Coating</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073701-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:43.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002462496</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073722-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002462502</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073724-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002462519</udiDi>
    <basicUdiDi>0827002CINC050-124_A1YQ</basicUdiDi>
    <tradeName>Urethral Dilator with AQ® Hydrophilic Coating</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073726-CD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:54:40.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849258</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4035.14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849272</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4045.14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849487</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849500</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028.10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849524</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849548</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4028.14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849562</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4035.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849586</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4035.10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849609</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4045.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098849623</udiDi>
    <basicUdiDi>04250098810084F2</basicUdiDi>
    <tradeName>UROMED UROporta Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4045.10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:28:00.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002303898</udiDi>
    <basicUdiDi>0827002CINC050-033_B-2JS</basicUdiDi>
    <tradeName>Flexor®</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>UNKNOWN</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FUS-140035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T19:50:20.904Z</lastUpdated>
  </row>
</eudamedExport>