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
    K830509

    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
    Tube, Tracheostomy (W/Wo Connector) BTO

    Proprietary Names

    Safeguard Control Cric

    Establishment Types

    Repack or Relabel Medical Device