BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Archer PSI System

    Reg #: 3013561205 · FEI: 3013561205 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    3D-SIDE
    Registration Number
    3013561205
    FEI Number
    3013561205
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue Dumont, 5
    City
    Mont Saint Guibert Brabant Wallon
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K243509

    Owner / Operator

    Firm Name
    3D-Side
    Operator Number
    10054501
    Address
    Fond des mes 4
    City
    Louvain-La-Neuve
    State
    Brabant Wallon
    Postal Code
    1348
    Country
    BE
    Correspondent
    Khanh Tran Duy

    Products

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

    Proprietary Names

    Archer PSI System

    Establishment Types

    Manufacture Medical Device