BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

    Reg #: 1225580 · FEI: 3012349753 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMC Ltd.
    Registration Number
    1225580
    FEI Number
    3012349753
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18 Independence Dr
    City
    Devens
    State
    MA
    ZIP
    01434
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160589

    Owner / Operator

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

    Products

    Device Name Product Code
    Epinephrine Syringe PQX

    Proprietary Names

    Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)