BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medifine Ultra

    Reg #: 3014393881 · FEI: 3014393881 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIBIO USA LLC
    Registration Number
    3014393881
    FEI Number
    3014393881
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12528 south Stonebrook Circle
    City
    Davie
    State
    FL
    ZIP
    33330
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171144

    Owner / Operator

    Firm Name
    Medibio USA LLC
    Operator Number
    10057070
    Address
    12528 south Stonebrook Circle
    City
    Davie
    State
    FL
    Postal Code
    33330
    Country
    US
    Correspondent
    Jatin Rajani

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Medifine Ultra Medifine Carefine Carefine Ultra TRUEplus 5 bevel Sterile pen needles TRUEplus 3 bevel Sterile pen needles

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198