BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    COOK IRELAND LTD

    Reg #: 3001845648 · FEI: 3001845648 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    19

    Registration Details

    Registration Name
    COOK IRELAND LTD
    Registration Number
    3001845648
    FEI Number
    3001845648
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    O HALLORAN ROAD, NATIONAL TECHNOLOGY PARK
    City
    LIMERICK
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K182980
    PMA Number
    P200023

    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
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Stent, Iliac Vein QAN
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Biopsy Needle FCG
    Stent, Superficial Femoral Artery NIP
    Stent, Iliac NIO
    Stent, Ureteral FAD
    Prosthesis, Esophageal ESW
    Endoscopic Transhepatic Venous Access Needle QIJ
    Ligator, Hemorrhoidal FHN
    Anoscope And Accessories FER
    Stent, Metallic, Expandable, Duodenal MUM
    Stent, Colonic, Metallic, Expandable MQR
    Accessories, Cleaning Brushes, For Endoscope MNL
    Forceps, Biopsy, Non-Electric FCL
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG

    Proprietary Names

    Nasal Pancreatic Drainage Set EchoTip ClearCore EUS Biopsy Needle Nagaraja Nasal Biliary Drainage Set Nasal Biliary Drainage Set Liguory Nasal Biliary Drainage Set Leung Nasal Biliary Drainage Set Compass BDS® Biliary Stent EchoTip Insight Portosystemic Pressure Gradient Measuring System EchoTip AcuCoreTM EUS Biopsy Needle Marcon Colon Decompression Set Colon Decompression Set 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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device