BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Safeguard

    Reg #: 3008258694 · FEI: 3008258694 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SAFEGUARD US OPERATING, LLC
    Registration Number
    3008258694
    FEI Number
    3008258694
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    ZIP
    28078
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120661

    Owner / Operator

    Firm Name
    Safeguard US Holdco, Inc.
    Operator Number
    10031323
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    Postal Code
    28078
    Country
    US
    Correspondent
    Kimberly Reed

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Safeguard Talon

    Establishment Types

    Repack or Relabel Medical Device