BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Healeon HD PRP,

    Reg #: 3004112621 · FEI: 3004112621 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KMI IMI GROUP / DBA: INNOVATIVE MED, INC.
    Registration Number
    3004112621
    FEI Number
    3004112621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4 Autry Suite B
    City
    IRVINE
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK170136

    Owner / Operator

    Firm Name
    KMI IMI GROUP / DBA INNOVATIVE MED, INC.
    Operator Number
    9058238
    Address
    4 AUTRY
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Natalie Cruze

    Products

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

    Proprietary Names

    Healeon HD PRP, Automated blood cell separator ProGen PRP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)