BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Aequalis Reversed Shoulder Prosthesis

    Reg #: 3007740680 · FEI: 3007740680 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    APS MATERIALS INC. IRELAND
    Registration Number
    3007740680
    FEI Number
    3007740680
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
    City
    Waterford
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K132285

    Owner / Operator

    Firm Name
    APS Materials Inc. Ireland
    Operator Number
    10029870
    Address
    Unit 26A, Waterford Industrial Estate, Cork Road, Waterford
    City
    Waterford
    State
    IE-WD
    Postal Code
    X91F670
    Country
    IE
    Correspondent
    Caroline Butler

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    Aequalis Reversed Shoulder Prosthesis

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)