BEUDAMED
    FDA Registration Active 🇨🇳 China

    ValvuloPro

    Reg #: 3013152301 · FEI: 3013152301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DONGGUAN TT MEDICAL, INC.
    Registration Number
    3013152301
    FEI Number
    3013152301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bld# 1, 1 Taoyuan Road,, Songshan Lake National High-Tech Industrial Park
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K231814

    Owner / Operator

    Firm Name
    Dongguan TT Medical, Inc.
    Operator Number
    10088168
    Address
    Bld# 1, 1 Taoyuan Road,, Songshan Lake National High-Tech Industrial Park
    City
    Dongguan
    State
    Guangdong
    Postal Code
    523808
    Country
    CN
    Correspondent
    Tim Wu

    US Agent

    Business Name
    TT MEDICAL USA, LLC
    Contact Name
    Edwards Kislauskis
    Address
    62 Strawberry Ln
    City
    Duxbury
    State
    MA
    ZIP
    02332
    Country
    US
    Email
    [email protected]
    Phone
    508 2692074

    Products

    Device Name Product Code
    Balloon Aortic Valvuloplasty OZT

    Proprietary Names

    ValvuloPro

    Establishment Types

    Manufacture Medical Device