BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Given Imaging Vietnam Co., Ltd.

    Reg #: 3007662958 · FEI: 3007662958 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Given Imaging Vietnam Co., Ltd.
    Registration Number
    3007662958
    FEI Number
    3007662958
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Suite 6A, 6 floor, Standard Factory Bldg., 14th Street, Tan Thuan EPZ, Tan Thuan Dong Ward
    City
    Ho Chi Minh City
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K012891

    Owner / Operator

    Firm Name
    GIVEN IMAGING INC.
    Operator Number
    10091555
    Address
    15 HAMPSHIRE STREET
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US
    Correspondent
    AVISHAG METZER

    US Agent

    Business Name
    Medtronic, Inc.
    Contact Name
    Marsha Seetaram
    Address
    710 Medtronic Pkwy
    City
    Minneapolis
    State
    MN
    ZIP
    55432
    Country
    US
    Email
    [email protected]
    Phone
    904 2812763

    Products

    Device Name Product Code
    Oximeter, Ear DPZ
    Oximeter DQA
    System, Gastrointestinal Motility (Electrical) FFX
    Electrode, Ph, Stomach FFT

    Proprietary Names

    Oximax Pulse Oximetry System Disposable Balloons Manoscan catheters ManoScan sw ManoView AR sw ManoScan Impedance module (Z) A200 ManoShield (disposable sanitary sheaths) ManoView ESO sw ManoScan 3D HRM A300 module ManoScan base pressure module ( A120) ManoScan System Versaflex pH Z catheters pHersaflex pH catheters Digitrapper pH Z Versaflex pH catheters Reflux software AccuView pH & pH-Z software

    Establishment Types

    Manufacture Medical Device