BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Performax

    Reg #: 3000143502 · FEI: 3000143502 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.
    Registration Number
    3000143502
    FEI Number
    3000143502
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    330 SMC Drive
    City
    Somerset
    State
    WI
    ZIP
    54025
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120562

    Owner / Operator

    Firm Name
    SCIENTIFIC MOLDING CORPORATION LTD
    Operator Number
    9057460
    Address
    330 SMC DRIVE, --
    City
    Somerset
    State
    WI
    Postal Code
    54025
    Country
    US
    Correspondent
    SHU - LI

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Performax FitLife

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)