BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bimini Health Tech

    Reg #: 3022978896 · FEI: 3022978896 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    22
    Establishment Types
    4
    Classifications
    6

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Bimini Health Tech
    Registration Number
    3022978896
    FEI Number
    3022978896
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8400 Belleview Drive, Ste. 125
    City
    Plano
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK220693
    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
    Lipoaspirate Washing System For Aesthetic Body Contouring QKL
    Instrument, Manual, Surgical, General Use MDM
    Stand, Infusion FOX
    Platelet And Plasma Separator For Bone Graft Handling ORG
    System, Suction, Lipoplasty For Removal QPB
    Prosthesis, Breast, Inflatable, Internal, Saline FWM

    Proprietary Names

    Puregraft 850 Puregraft 850 Twin Pack AutoPose Restore Dermapose Refresh Puregraft Vacuum Lid Puregraft Combined Adapter Vacuum Lid - Port Replacement Kit Vacuum Lid - O-Ring Kit Dermapose Refresh Stand DIRECT2 Lid, Drain Lever Replacement Kit DIRECT2 Lid, Drain Port Replacement Kit DIRECT2 Lid Puregraft SYNC Puregraft Instrument Set Puregraft 250 Healeon Duet Amplifine Adaptive Dermapose Access Ideal Implant Puregraft Serene Breast Implant Puregraft 50

    Establishment Types

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