BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RegenKit-BCT-1 Plus

    Reg #: 3010512490 · FEI: 3010512490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Regenlab USA LLC
    Registration Number
    3010512490
    FEI Number
    3010512490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    95 Greene St
    City
    Jersey City
    State
    NJ
    ZIP
    07302
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK120066

    Owner / Operator

    Firm Name
    RegenLab
    Operator Number
    10033110
    Address
    95 Greene St, Jersey City
    City
    Jersey City
    State
    NJ
    Postal Code
    07302
    Country
    US

    Products

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

    Proprietary Names

    RegenKit-BCT-1 Plus RegenKit-BCT-2 Plus

    Establishment Types

    Manufacture Medical Device