BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    SD-400U-10

    Reg #: 3008040402 · FEI: 3008040402 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Olympus Vietnam Co. Ltd.
    Registration Number
    3008040402
    FEI Number
    3008040402
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Street, Long Thanh Industrial Zone, Tam An Commune
    City
    Long Thanh District Dong Nai
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K172734

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    US Agent

    Business Name
    Gyrus ACMI, Inc.
    Contact Name
    Todd Brill
    Address
    800 West Park Drive, --
    City
    Westborough
    State
    MA
    ZIP
    01581
    Country
    US
    Email
    [email protected]
    Phone
    508 2077661

    Products

    Device Name Product Code
    Snare, Flexible FDI
    Snare, Non-Electrical FGX

    Proprietary Names

    SD-400U-10 SD-400U-15

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)