<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00827002502161</udiDi>
    <basicUdiDi>B-00827002502161</basicUdiDi>
    <tradeName>Advance® 18LP</tradeName>
    <deviceName>Advance® 18LP Low Profile PTA Balloon Dilatation Catheter</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTA4-18-135-3-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:48.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002502154</udiDi>
    <basicUdiDi>B-00827002502154</basicUdiDi>
    <tradeName>Advance® 18LP</tradeName>
    <deviceName>Advance® 18LP Low Profile PTA Ballon Dilatation Catheter</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTA4-18-80-3-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:48.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002502147</udiDi>
    <basicUdiDi>B-00827002502147</basicUdiDi>
    <tradeName>00827002502147</tradeName>
    <deviceName>TFE Sheathed Needle With Chiba Tip and Clear Sheath</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>MDD</legislation>
    <emdnCode>A019013</emdnCode>
    <emdnDescription>PERCUTANEOUS NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>090060-CS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:46.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002495739</udiDi>
    <basicUdiDi>B-00827002495739</basicUdiDi>
    <tradeName>00827002495739</tradeName>
    <deviceName>FUSION BILIARY DILATION CATHETER</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010202</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDC-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:44.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002495715</udiDi>
    <basicUdiDi>B-00827002495715</basicUdiDi>
    <tradeName>00827002495715</tradeName>
    <deviceName>FUSION BILIARY DILATION CATHETER</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010202</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDC-7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:42.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002494794</udiDi>
    <basicUdiDi>B-00827002494794</basicUdiDi>
    <tradeName>Advance® 18LP</tradeName>
    <deviceName>Advance® 18LP Low Profile PTA Balloon Dilatation Catheter</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTA4-18-135-4-8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:41.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002495722</udiDi>
    <basicUdiDi>B-00827002495722</basicUdiDi>
    <tradeName>00827002495722</tradeName>
    <deviceName>FUSION BILIARY DILATION CATHETER</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010202</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE FLEXIBLE DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDC-8.5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:40.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492752</udiDi>
    <basicUdiDi>B-00827002492752</basicUdiDi>
    <tradeName>00827002492752</tradeName>
    <deviceName>Vacuum Pump</deviceName>
    <manufacturerName>William A. Cook Australia Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000002276</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-MAR-5200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:26.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492226</udiDi>
    <basicUdiDi>B-00827002492226</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</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>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-10X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:22.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492219</udiDi>
    <basicUdiDi>B-00827002492219</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</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>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-8X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:21.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492202</udiDi>
    <basicUdiDi>B-00827002492202</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</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>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-6X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:20.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492196</udiDi>
    <basicUdiDi>B-00827002492196</basicUdiDi>
    <tradeName>Fusion® Titan™</tradeName>
    <deviceName>Fusion® Titan™ Biliary Dilation Balloon</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>MDD</legislation>
    <emdnCode>G0301010402</emdnCode>
    <emdnDescription>BILIARY BALLOON CATHETERS, HIGH PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-BDB-4X4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:20.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002487321</udiDi>
    <basicUdiDi>B-00827002487321</basicUdiDi>
    <tradeName>00827002487321</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-15-16.5-18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:16.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484115</udiDi>
    <basicUdiDi>B-00827002484115</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-828-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:15.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484108</udiDi>
    <basicUdiDi>B-00827002484108</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-826-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:14.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484092</udiDi>
    <basicUdiDi>B-00827002484092</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-824-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:13.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484061</udiDi>
    <basicUdiDi>B-00827002484061</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-818-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:09.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484054</udiDi>
    <basicUdiDi>B-00827002484054</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-800-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:08.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484030</udiDi>
    <basicUdiDi>B-00827002484030</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-822-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:08.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002484023</udiDi>
    <basicUdiDi>B-00827002484023</basicUdiDi>
    <tradeName>Soft Ureteral Stent Set with Monofilament Tether</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</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>US-820-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:07.252Z</lastUpdated>
  </row>
</eudamedExport>