BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Unistik HeelStik - Preemie

    Reg #: 8021764 · FEI: 3000191104 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OWEN MUMFORD, LTD.
    Registration Number
    8021764
    FEI Number
    3000191104
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BROOK HILL
    City
    WOODSTOCK, OXFORDSHIRE
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K222168

    Owner / Operator

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

    US Agent

    Business Name
    OWEN MUMFORD USA, INC
    Contact Name
    TRAVIS SHAW
    Address
    1755 WEST OAK COMMONS CT
    City
    Marietta
    State
    GA
    ZIP
    30062
    Country
    US
    Email
    [email protected]
    Phone
    770 9772226

    Products

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

    Proprietary Names

    Unistik HeelStik - Preemie Unistik TinyTouch - Full-Term Unistik TinyTouch - Preemie Unistik HeelStik - MicroPreemie Unistik HeelStik - Toddler Unistik HeelStik - Full Term

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198