BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Puregraft Serene Breast Implant

    Reg #: 3022978896 · FEI: 3022978896 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Bimini Health Tech
    Registration Number
    3022978896
    FEI Number
    3022978896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8400 Belleview Drive, Ste. 125
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    PMA Number
    P120011

    Owner / Operator

    Firm Name
    Bimini Health Tech
    Operator Number
    10048045
    Address
    8400 Belleview Drive, Suite 125
    City
    Plano
    State
    TX
    Postal Code
    75024
    Country
    US
    Correspondent
    Frankie Ng

    Products

    Device Name Product Code
    Prosthesis, Breast, Inflatable, Internal, Saline FWM

    Proprietary Names

    Puregraft Serene Breast Implant Ideal Implant

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility