BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Hygeia FIT

    Reg #: 3006774448 · FEI: 3006774448 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HYGEIA II MEDICAL GROUP, INC.
    Registration Number
    3006774448
    FEI Number
    3006774448
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6241 Yarrow Dr Ste A
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162870

    Owner / Operator

    Firm Name
    Hygeia II Medical Group, Inc.
    Operator Number
    10025094
    Address
    6241 Yarrow Dr., Suite A
    City
    Carlsbad
    State
    CA
    Postal Code
    92011
    Country
    US

    Products

    Device Name Product Code
    Pump, Breast, Powered HGX

    Proprietary Names

    Hygeia FIT

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198