BEUDAMED
    FDA Registration Active 🇨🇳 China

    Saphenous Vein Distention System, irrigation beveled and blunt cannula, sterile and nonsterile

    Reg #: 3009107690 · FEI: 3009107690 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Medwell Technology Limited
    Registration Number
    3009107690
    FEI Number
    3009107690
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2nd Floor, 5th Building No. 136 Gangjian Road, Changping Town
    City
    Dongguan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K000704

    Owner / Operator

    Firm Name
    Medwell Technology Limited
    Operator Number
    10041301
    Address
    2nd Floor, 5th Building No. 136 Gangjian Road, Changping Town
    City
    Dongguan City
    State
    Guangdong
    Postal Code
    523570
    Country
    CN
    Correspondent
    Andy Song

    US Agent

    Business Name
    Mazza Healthcare, LLC
    Contact Name
    Amy Orrell
    Address
    2101 Waukegan Road, Suite 208
    City
    Bannockburn
    State
    IL
    ZIP
    60015
    Country
    US
    Email
    [email protected]
    Phone
    847 2823444

    Products

    Device Name Product Code
    Catheter, Irrigation GBX

    Proprietary Names

    Saphenous Vein Distention System, irrigation beveled and blunt cannula, sterile and nonsterile

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)