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Data / Medical devices / Germany / Cook Medical EUDC GmbH

Cook Medical EUDC GmbH: FDA-registered device maker in Baesweiler North Rhine-Westphalia, Germany, 25 510(k) clearances and 5 PMA approvals

Cook Medical EUDC GmbH is registered with the FDA (registration 3009526575) in Baesweiler North Rhine-Westphalia, Germany. It lists 24 device types. The FDA files 25 510(k) clearances and 5 PMA approvals under its listings, the newest dated July 29, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Cook Medical EUDC GmbH
FDA registration number
3009526575
Address
Robert Koch StraBe 2, Baesweiler North Rhine-Westphalia, Germany, 52499
Owner or operator
COOK IRELAND LTD (9052427)
Roles
Exporter to the US, Foreign private label distributor
First device listed
October 30, 2006
Registered through
2026
Brand names listed
Colon Decompression Set, Compass BDS® Biliary Stent, EchoTip AcuCoreTM EUS Biopsy Needle, EchoTip ClearCore EUS Biopsy Needle, EchoTip Insight Portosystemic Pressure Gradient Measuring System, EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Olypmus Scopes, EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Pentax Scopes, EchoTip Procore HD Ultrasound Biopsy Needle and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Cleaning Brushes, For EndoscopeMNL1Exporter to the USaccessdata.fda.gov
Anoscope And AccessoriesFER2Exporter to the USaccessdata.fda.gov
Biopsy NeedleFCG2Exporter to the US, Foreign private label distributoraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Exporter to the USaccessdata.fda.gov
Endoscopic Transhepatic Venous Access NeedleQIJ2Exporter to the USaccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Exporter to the USaccessdata.fda.gov
Filter, Intravascular, CardiovascularDTK2Exporter to the USaccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Exporter to the USaccessdata.fda.gov
Ligator, HemorrhoidalFHN2Exporter to the USaccessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)BSP2Exporter to the USaccessdata.fda.gov
Prosthesis, EsophagealESW2Exporter to the USaccessdata.fda.gov
Stent, Colonic, Metallic, ExpandableMQR2Exporter to the USaccessdata.fda.gov
Stent, IliacNIO3Exporter to the USaccessdata.fda.gov
Stent, Iliac VeinQAN3Exporter to the USaccessdata.fda.gov
Stent, Metallic, Expandable, DuodenalMUM2Exporter to the USaccessdata.fda.gov
Stent, Superficial Femoral ArteryNIP3Exporter to the USaccessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-ElutingNIU3Exporter to the USaccessdata.fda.gov
Stent, UreteralFAD2Exporter to the USaccessdata.fda.gov
Stents, Drains And Dilators For The Biliary DuctsFGE2Exporter to the USaccessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm TreatmentMIH3Exporter to the USaccessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or IntubationFEG2Exporter to the USaccessdata.fda.gov
Tube, Tracheal (W/Wo Connector)BTR2Exporter to the USaccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Exporter to the USaccessdata.fda.gov
Wire, Guide, CatheterDQX2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 29, 2024K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)FCGSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
June 14, 2024K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)FGESubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
January 18, 2024K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterDTKSubstantially EquivalentWilliam Cook Europe Apsaccessdata.fda.gov
May 30, 2023K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)FCGSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
May 9, 2022K213946Compass BDS Biliary StentFGESubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
February 17, 2022K220137Lunderquist Extra Stiff Wire GuideDQXSubstantially EquivalentWilliam Cook Europe Apsaccessdata.fda.gov
November 20, 2019DEN180062EchoTip Insight Portosystemic Pressure Gradient Measuring SystemQIJUnknownCook Ireland, Ltd.accessdata.fda.gov
November 16, 2018K182980Zilver 518 Biliary Stent, Zilver 635 Biliary StentFGEUnknownCook Ireland, Ltd.accessdata.fda.gov
July 6, 2018K180868Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage SetFGESubstantially EquivalentCook Irelandaccessdata.fda.gov
February 27, 2018K172044Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action SFGESubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
August 1, 2017K17161914Fr Colon Decompression Set, Macon Colon Decompression SetFEGSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
July 31, 2017K171623Nasal Pancreatic Drainage SetFGESubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
May 19, 2017K161813Frova Intubating IntroducerBTRSubstantially EquivalentWilliam Cook Europe Apsaccessdata.fda.gov
May 4, 2017K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - UncoveredMUMSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
December 23, 2016K163018Zilver 635 Biliary StentFGEUnknownCook Ireland, Ltd.accessdata.fda.gov
December 21, 2016K162717Evolution Esophageal Stent System – Partially CoveredESWSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
December 18, 2015K150964MReye Flipper Detachable Embolization Coil and Delivery SystemKRDSubstantially EquivalentCook Incorporatedaccessdata.fda.gov
March 1, 2013K121430EVOLUTION BILIARY STENT SYSTEMFGEUnknownCook Ireland, Ltd.accessdata.fda.gov
June 17, 2010K093619EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-EESWSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
November 2, 2009K092359ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19AFCGSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
May 8, 2007K063742RESONANCE METALLIC URETERAL STENTFADSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
September 6, 2006K060623SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPEFERSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
April 22, 2005K050578COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICEKNSSubstantially EquivalentCook Ireland, Ltd.accessdata.fda.gov
May 27, 2003K030618WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLEBSPSubstantially EquivalentWilson-Cook Medical, Inc.accessdata.fda.gov
October 17, 2002K022595WILSON-COOK CYSTOTOMEKNSSubstantially EquivalentWilson-Cook Medical, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
October 9, 2020P200023Zilver Vena Venous Self-Expanding StentQAN9April 14, 2026accessdata.fda.gov
December 31, 2018P180001Zenith Dissection Endovascular SystemMIH17August 4, 2026accessdata.fda.gov
September 15, 2015P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTMIH18August 4, 2026accessdata.fda.gov
November 14, 2012P100022ZILVER PTX DRUG-ELUTING PERIPHERAL STENTNIU43March 25, 2026accessdata.fda.gov
June 26, 2006P050017ZILVER VASCULAR STENTNIO25April 14, 2026accessdata.fda.gov

Compare with other makers

Updated April 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.