BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HYGEIA II MEDICAL GROUP, INC.

    Reg #: 3006774448 · FEI: 3006774448 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HYGEIA II MEDICAL GROUP, INC.
    Registration Number
    3006774448
    FEI Number
    3006774448
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6241 Yarrow Dr Ste A
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K200406

    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, Non-Powered HGY
    Pump, Breast, Powered HGX

    Proprietary Names

    EnHande Manual Breast Pump Hygeia 2 Hand Manual Breast Pump EVOLVE Nova Luxe Q EnRiche EnJoye EnDeare Hygeia FIT EXPRESS LITE Hygeia Express Powered Breast Pump

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198