BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vensure Balloon dilation system

    Reg #: 1646831 · FEI: 1000160215 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOMERICS FMI
    Registration Number
    1646831
    FEI Number
    1000160215
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1605/1704/1700 Enterprise St.
    City
    Athens
    State
    TX
    ZIP
    75751
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230065

    Owner / Operator

    Firm Name
    Biomerics FMI
    Operator Number
    9008904
    Address
    1605/1704/1700 ENTERPRISE ST., --
    City
    Athens
    State
    TX
    Postal Code
    75751
    Country
    US
    Correspondent
    STACEY - LYONS

    Products

    Device Name Product Code
    Eustachian Tube Balloon Dilation Device PNZ
    Instrument, Ent Manual Surgical LRC

    Proprietary Names

    Vensure Balloon dilation system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)