BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Cook Medical EUDC GmbH

    Reg #: 3009526575 · FEI: 3009526575 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    24

    Registration Details

    Registration Name
    Cook Medical EUDC GmbH
    Registration Number
    3009526575
    FEI Number
    3009526575
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Robert Koch StraBe 2
    City
    Baesweiler North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K063742
    PMA Number
    P100022

    Owner / Operator

    Firm Name
    COOK IRELAND LTD
    Operator Number
    9052427
    Address
    O'HALLORAN ROAD, NATIONAL TECHNOLOGY PARK
    City
    LIMERICK
    State
    IE-LK
    Postal Code
    00000
    Country
    IE
    Correspondent
    Sinead Egan

    US Agent

    Business Name
    Cook Medical Holdings LLC
    Contact Name
    Matt Graf
    Address
    750 Daniels Way
    City
    Bloomington
    State
    IN
    ZIP
    47404
    Country
    US
    Email
    [email protected]
    Phone
    812 3392235

    Products

    Device Name Product Code
    Stent, Ureteral FAD
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Biopsy Needle FCG
    Stent, Metallic, Expandable, Duodenal MUM
    Stent, Colonic, Metallic, Expandable MQR
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Ligator, Hemorrhoidal FHN
    Anoscope And Accessories FER
    Prosthesis, Esophageal ESW
    Wire, Guide, Catheter DQX
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Accessories, Cleaning Brushes, For Endoscope MNL
    Endoscopic Transhepatic Venous Access Needle QIJ
    Filter, Intravascular, Cardiovascular DTK
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Stent, Superficial Femoral Artery NIP
    Stent, Iliac NIO
    Forceps, Biopsy, Non-Electric FCL
    Tube, Tracheal (W/Wo Connector) BTR
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Device, Vascular, For Promoting Embolization KRD
    Stent, Iliac Vein QAN
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG

    Proprietary Names

    EchoTip ClearCore EUS Biopsy Needle Compass BDS® Biliary Stent Lunderquist Extra Stiff Wire Guide, DC Wire Guides EchoTip Ultra Endoscopic Ultrasound Needle EchoTip Ultra Endobronchial High Definition Ultrasound Needle EchoTip Procore HD Ultrasound Biopsy Needle EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Pentax Scopes EchoTip Procore Endobronchial High Definition Ultrasound Biopsy Needle for Olypmus Scopes EchoTip Insight Portosystemic Pressure Gradient Measuring System EchoTip AcuCoreTM EUS Biopsy Needle Nagaraja Nasal Biliary Drainage Set Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Set Leung Nasal Biliary Drainage Set Marcon Colon Decompression Set Colon Decompression Set Nasal Pancreatic Drainage Set

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor