BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Celsi Monitor

    Reg #: 3014263632 · FEI: 3014263632 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ITEK
    Registration Number
    3014263632
    FEI Number
    3014263632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zona Franca La Lima, Edificio MT4
    City
    Cartago
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K230298

    Owner / Operator

    Firm Name
    ITEK
    Operator Number
    10087095
    Address
    Zona Franca La Lima, Edificio MT4
    City
    Cartago
    State
    CR-C
    Postal Code
    30106
    Country
    CR
    Correspondent
    Bernal Rodriguez

    US Agent

    Business Name
    DD Global MedDev Consulting
    Contact Name
    Donna Djinovich
    Address
    501 N Clinton St Apt 907
    City
    Chicago
    State
    IL
    ZIP
    60654
    Country
    US
    Email
    [email protected]
    Phone
    847 9035920

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL
    Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) MHX

    Proprietary Names

    Celsi Monitor

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)