BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Anteris Aus Operations Pty Ltd

    Reg #: 3010805634 · FEI: 3010805634 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Anteris Aus Operations Pty Ltd
    Registration Number
    3010805634
    FEI Number
    3010805634
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    26 Harris Road
    City
    Malaga Western Australia
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K200566

    Owner / Operator

    Firm Name
    Anteris Technology Corporation
    Operator Number
    10046278
    Address
    860 Blue Gentian Road, Suite 340
    City
    Eagan
    State
    MN
    Postal Code
    55121
    Country
    US
    Correspondent
    Renee Cveykus

    US Agent

    Business Name
    Anteris Technologies Corporation
    Contact Name
    Renee Cveykus
    Address
    860 Blue Gentian Rd
    City
    Eagan
    State
    MN
    ZIP
    55121
    Country
    US
    Email
    [email protected]
    Phone
    651 4930606

    Products

    Device Name Product Code
    Intracardiac Patch Or Pledget, Biologically Derived PSQ

    Proprietary Names

    ADAPT Tissue

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device