BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Owen Mumford Sdn Bhd

    Reg #: 3013143994 · FEI: 3013143994 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    20
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    Owen Mumford Sdn Bhd
    Registration Number
    3013143994
    FEI Number
    3013143994
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 19 & 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC
    City
    Iskandar Puteri Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K221126

    Owner / Operator

    Firm Name
    OWEN MUMFORD, LTD.
    Operator Number
    8021764
    Address
    Primsdown Industrial Estate, Chipping Norton
    City
    OXFORDSHIRE
    State
    GB-NOTA
    Postal Code
    0X7 5XP
    Country
    GB

    US Agent

    Business Name
    OWEN MUMFORD USA INCORPORATED
    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
    Introducer, Syringe Needle KZH
    Stent, Vaginal KXP
    Esthesiometer GXB
    Device, External Penile Rigidity LKY

    Proprietary Names

    Unistik 3 Unistik Autoject 2 Rebiject II Fixed Needle Betaject Lite Extavia Auto-Injector II AUTOJECT 2 (NON-FIXED NEEDLE) Amielle NEUROPEN NEUROTIP Autoject II Unistik Touch Unistik Pro Autolet Plus Unilet ComforTouch Unistik TinyTouch Autolet Unilet AUTOJECT 2 (FIXED NEEDLE)

    Establishment Types

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