BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Extavia Auto-Injector II

    Reg #: 3003348846 · FEI: 3003348846 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    5
    Classifications
    1

    Registration Details

    Registration Name
    Owen Mumford Limited
    Registration Number
    3003348846
    FEI Number
    3003348846
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Primsdown Industrial Estate, Worcester Road
    City
    Chipping Norton Oxfordshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K993385

    Owner / Operator

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

    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
    Introducer, Syringe Needle KZH

    Proprietary Names

    Extavia Auto-Injector II Betaject Lite AUTOJECT 2 (NON-FIXED NEEDLE)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Foreign Private Label Distributor Repack or Relabel Medical Device Manufacture Medical Device