BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    CAPE HEALTHCARE SYSTEMS S.A.

    Reg #: 3035363852 · FEI: 3035363852 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    CAPE HEALTHCARE SYSTEMS S.A.
    Registration Number
    3035363852
    FEI Number
    3035363852
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Norte, 50 Oeste y 50 Norte del Pali de la Florida
    City
    San Juan de Tibas San Jose
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K192903

    Owner / Operator

    Firm Name
    Cape Healthcare Systems S.A.
    Operator Number
    10092872
    Address
    100 Norte, 50 Oeste y 50 Norte del Pali de la Florida
    City
    San Juan de Tibas
    State
    San Jose
    Postal Code
    11301
    Country
    CR

    US Agent

    Business Name
    Registrar Corp.
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177 ext. 200

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Establishment Types

    Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device