BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INVOcell

    Reg #: 3008101047 · FEI: 3008101047 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    INVO Fertility, Inc.
    Registration Number
    3008101047
    FEI Number
    3008101047
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5582 Broadcast Court
    City
    Sarasota
    State
    FL
    ZIP
    34240
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN150008

    Owner / Operator

    Firm Name
    INVO Fertility, Inc.
    Operator Number
    10035355
    Address
    5582 Broadcast Court
    City
    Sarasota
    State
    FL
    Postal Code
    34240
    Country
    US
    Correspondent
    Chris Jensen

    Products

    Device Name Product Code
    Culture, Intravaginal, Assisted Reproduction OYO

    Proprietary Names

    INVOcell

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device