BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Direct Cell

    Reg #: 3008773560 · FEI: 3008773560 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOGENNIX, LLC
    Registration Number
    3008773560
    FEI Number
    3008773560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    18009 Sky Park Cir Ste K
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190177

    Owner / Operator

    Firm Name
    Biogennix, LLC
    Operator Number
    10030571
    Address
    18007 Sky Park Circle, Suite D
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US
    Correspondent
    Edwin C Shors

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Biopsy Needle FCG

    Proprietary Names

    Direct Cell

    Establishment Types

    Repack or Relabel Medical Device