BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Adaptive Autologous Processing System

    Reg #: 3016948539 · FEI: 3008066433 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GENESIS BIOLOGICS, INC.
    Registration Number
    3016948539
    FEI Number
    3008066433
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17791 Mitchell North, Suite D
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK230807

    Owner / Operator

    Firm Name
    Genesis Biologics, Inc.
    Operator Number
    10074842
    Address
    17791 Mitchell North, Suite D
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Steven Bee

    Products

    Device Name Product Code
    Platelet And Plasma Separator For Bone Graft Handling ORG

    Proprietary Names

    Adaptive Autologous Processing System

    Establishment Types

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