BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Motiva SmoothSilk Round and SmoothSilk Ergonomix Breast Implants

    Reg #: 3012883202 · FEI: 3012883202 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ESTABLISHMENT LABS S.A.
    Registration Number
    3012883202
    FEI Number
    3012883202
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Coyol Free Zone & Business Park Building, 4th Street, Building B-15
    City
    Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    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

    Proprietary Names

    Motiva SmoothSilk Round and SmoothSilk Ergonomix Breast Implants

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device