BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Accessory, Ventilator Effort Recorder -zRIPWireset,AlicePDx

    Reg #: 3009327445 · FEI: 3009327445 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SMC Costa Rica Division S.R.L.
    Registration Number
    3009327445
    FEI Number
    3009327445
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Building B48, Ave 0, Zona Franca Coyol
    City
    El Coyol Alajuela
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K013905

    Owner / Operator

    Firm Name
    SCIENTIFIC MOLDING CORPORATION LTD
    Operator Number
    9057460
    Address
    330 SMC DRIVE, --
    City
    Somerset
    State
    WI
    Postal Code
    54025
    Country
    US

    US Agent

    Business Name
    SCIENTIFIC MOLDING CORPORATION LTD
    Contact Name
    Bryan Moris
    Address
    330 Smc Dr
    City
    Somerset
    State
    WI
    ZIP
    54025
    Country
    US
    Email
    [email protected]
    Phone
    715 2473500

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Accessory, Ventilator Effort Recorder -zRIPWireset,AlicePDx zRIPCableRibcage,QDC zRIPCableAbdomen,QDC ZRIP Wireset Quantum Sensor size 1, 49" to 75" Quantum Sensor size 2, 15" to 25" Quantum Sensor size 1, 10" to 16" Quantum Sensor size 4, 34" to 50" Quantum Sensor size 3, 24" to 35"

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)