BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Edwards Crimper

    Reg #: 3010432890 · FEI: 3010432890 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Costa Rica S.R.L.
    Registration Number
    3010432890
    FEI Number
    3010432890
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Franca PROPARK, Calle Principal, Edificio 10
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    PMA Number
    P140031

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    Edwards Crimper Edwards Commander Delivery System Edwards Certitude Delivery System Edwards SAPIEN 3 Transcatheter Heart Valve Edwards Certitude Introducer Sheath Set Edwards SAPIEN 3 Ultra Delivery System eSheath- 916ES Edwards Axela Sheath eSheath- 914ES Edwards eSheath Introducer Set- 914ES Edwards eSheath Introducer Set- 916ES Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)