BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    WILLIAM A. COOK AUSTRALIA PTY, LTD.

    Reg #: 9680654 · FEI: 3007530363 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    WILLIAM A. COOK AUSTRALIA PTY, LTD.
    Registration Number
    9680654
    FEI Number
    3007530363
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    95 BRANDL ST
    City
    EIGHT MILE PLAINS Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K160753
    PMA Number
    P020018

    Owner / Operator

    Firm Name
    William A Cook Australia Pty Ltd
    Operator Number
    9010455
    Address
    95 Brandl Street, --
    City
    Eight Mile Plains
    State
    Queensland
    Postal Code
    4113
    Country
    AU
    Correspondent
    Hemangi - Malde

    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
    Accessory, Assisted Reproduction MQG
    Needle, Assisted Reproduction MQE
    System, Endovascular Graft, Aortic Aneurysm Treatment MIH
    Accessory, Assisted Reproduction, Exempt PUB

    Proprietary Names

    COOK Vacuum Pump Cook Ultra Quiet Vacuum Pump/Access Ovum Pick-Up Aspiration Needles Cook Mini-Incubator Single Lumen Ovum Aspiration Needles Zenith® Iliac Branch Zenith Fenestrated AAA Endovascular Graft Cook Test Tube Heater Double Lumen Ovum Aspiration Needles MINC+ Benchtop Incubator

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility