BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    ESTABLISHMENT LABS S.A.

    Reg #: 3012883202 · FEI: 3012883202 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ESTABLISHMENT LABS S.A.
    Registration Number
    3012883202
    FEI Number
    3012883202
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Coyol Free Zone & Business Park Building, 4th Street, Building B-15
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K211676
    PMA Number
    P230005

    Owner / Operator

    Firm Name
    Establishment Labs- Motiva USA LLC
    Operator Number
    10061559
    Address
    125 E. De la Guerra #203A
    City
    Santa Barbara
    State
    CA
    Postal Code
    93101
    Country
    US

    US Agent

    Business Name
    Motiva USA LLC
    Contact Name
    Rosalyn D'incelli
    Address
    125 E De La Guerra St Ste 203a
    City
    Santa Barbara
    State
    CA
    ZIP
    93101
    Country
    US
    Email
    [email protected]
    Phone
    805 4525421

    Products

    Device Name Product Code
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled FTR
    Expander, Surgical, Skin Graft FZW
    Tissue Expander And Accessories LCJ
    Mammary Sizer MRD

    Proprietary Names

    Motiva SmoothSilk Round and SmoothSilk Ergonomix Breast Implants Motiva Inflatable Balloon Motiva Flora SmoothSilk Tissue Expander Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198