BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OWEN MUMFORD USA, INC.

    Reg #: 1058602 · FEI: 1000219614 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    45
    Establishment Types
    2
    Classifications
    13

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    Registration Details

    Registration Name
    OWEN MUMFORD USA, INC.
    Registration Number
    1058602
    FEI Number
    1000219614
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1755 W Oak Commons Ct
    City
    MARIETTA
    State
    GA
    ZIP
    30062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242627

    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

    Products

    Device Name Product Code
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Needle, Hypodermic, Single Lumen FMI
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Exerciser, Non-Measuring ION
    Stent, Vaginal KXP
    Introducer, Syringe Needle KZH
    Esthesiometer GXB
    Device, External Penile Rigidity LKY
    Syringe, Piston FMF
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Dropper, Ent KCM
    Components, Exercise IOD

    Proprietary Names

    Unifine SafeControl Unifine Ultra Autolet Autolet Lite Unilet Unilet ComforTouch Unistik Touch Amielle Unistik TinyTouch - Preemie Unistik HeelStik - Preemie Unistik HeelStik - MicroPreemie Unistik HeelStik - Toddler Unistik HeelStik - Full Term Unistik TinyTouch - Full-Term Unistik 3 Unistik Betaject Lite Extavia Auto-Injector II AUTOJECT 2 (NON-FIXED NEEDLE) NEUROPEN NEUROTIP Unifine Pentips Unifine Pentips Plus Unistik Pro Autolet Plus Unistik TinyTouch Constriction Ring size 7 RAPPORT V.T.D. Constriction Ring size 5 Constriction Ring size 4 Constriction Ring size 6 Constriction Ring size 3 Constriction Ring size 8 Constriction Ring size 9 Autopen Classic 3ml Unistik Vacuflip Unistik Shieldlock AUTOSQUEEZE AUTODROP Autopen Classic Amielle Restore Autoject 2 Rebiject II Fixed Needle Pentips

    Establishment Types

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