<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00827002156968</udiDi>
    <basicUdiDi>B-00827002156968</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex® Multi-Length Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039600-R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:15.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002151932</udiDi>
    <basicUdiDi>B-00827002151932</basicUdiDi>
    <tradeName>00827002151932</tradeName>
    <deviceName>Black Silicone Filiform Double Pigtail Ureteral Stent</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:14.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002151505</udiDi>
    <basicUdiDi>B-00827002151505</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex® Multi-Length Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039500-S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:13.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002148970</udiDi>
    <basicUdiDi>B-00827002148970</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036322</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:12.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002148345</udiDi>
    <basicUdiDi>B-00827002148345</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:08.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147997</udiDi>
    <basicUdiDi>B-00827002147997</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:07.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147942</udiDi>
    <basicUdiDi>B-00827002147942</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036308</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:07.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147904</udiDi>
    <basicUdiDi>B-00827002147904</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex®Large Diameter Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:06.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147898</udiDi>
    <basicUdiDi>B-00827002147898</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex®Large Diameter Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:02.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147874</udiDi>
    <basicUdiDi>B-00827002147874</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036316</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:01.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147836</udiDi>
    <basicUdiDi>B-00827002147836</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex® Multi-Length Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:49:00.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147737</udiDi>
    <basicUdiDi>B-00827002147737</basicUdiDi>
    <tradeName>Sof-Flex®</tradeName>
    <deviceName>Sof-Flex® Multi-Length Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>039600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:48:59.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002147003</udiDi>
    <basicUdiDi>B-00827002147003</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:48:55.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002146396</udiDi>
    <basicUdiDi>B-00827002146396</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:48:55.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002146372</udiDi>
    <basicUdiDi>B-00827002146372</basicUdiDi>
    <tradeName>C-Flex®</tradeName>
    <deviceName>C-Flex® Double Pigtail Ureteral Stent Set</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>036310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:48:54.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756758342</udiDi>
    <basicUdiDi>69207567DNG0001GL</basicUdiDi>
    <tradeName>Foley Catheter for single use  latex Two-way with ballone 2.7mm(8Fr)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR08D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:15.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756758359</udiDi>
    <basicUdiDi>69207567DNG0001GL</basicUdiDi>
    <tradeName>Foley Catheter for single use ）3.3mm(10Fr)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR10D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:15.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756758366</udiDi>
    <basicUdiDi>69207567DNG0001GL</basicUdiDi>
    <tradeName>Foley Catheter for single use [ latex Two-way with ballone) 4.0mm(12Fr)]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR12D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:15.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756758373</udiDi>
    <basicUdiDi>69207567DNG0001GL</basicUdiDi>
    <tradeName>Foley Catheter for single use [ latex Two-way with ballone) 4.7mm(14Fr)]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR14D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:15.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06920756758380</udiDi>
    <basicUdiDi>69207567DNG0001GL</basicUdiDi>
    <tradeName>Foley Catheter for single use [ latex Two-way with ballone)  5.3mm(16Fr)]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangxi Hongda Medical Equipment Group Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006019</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U020202</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH FLUTE TIP WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR16D</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-17T05:00:15.686Z</lastUpdated>
  </row>
</eudamedExport>