BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    EchoTip ClearCore EUS Biopsy Needle

    Reg #: 3009526575 · FEI: 3009526575 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Cook Medical EUDC GmbH
    Registration Number
    3009526575
    FEI Number
    3009526575
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Robert Koch StraBe 2
    City
    Baesweiler North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K230909

    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
    Biopsy Needle FCG
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG

    Proprietary Names

    EchoTip ClearCore EUS Biopsy Needle EchoTip AcuCoreTM EUS Biopsy Needle

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device