BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Unistik Touch

    Reg #: 1058602 · FEI: 1000219614 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    OWEN MUMFORD USA, INC.
    Registration Number
    1058602
    FEI Number
    1000219614
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1755 W Oak Commons Ct
    City
    MARIETTA
    State
    GA
    ZIP
    30062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222111

    Owner / Operator

    Firm Name
    OWEN MUMFORD, LTD.
    Operator Number
    8021764
    Address
    BROOK HILL, WOODSTOCK
    City
    OXFORDSHIRE
    State
    GB-NOTA
    Postal Code
    0X20ITU
    Country
    GB

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK

    Proprietary Names

    Unistik Touch

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device