BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Celsi Monitor

    Reg #: 3030597679 · FEI: 3030597679 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HADLEIGH HEALTH TECHNOLOGIES
    Registration Number
    3030597679
    FEI Number
    3030597679
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 Gate 5 Road, Suite 215
    City
    Sausalito
    State
    CA
    ZIP
    94965
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230298

    Owner / Operator

    Firm Name
    Hadleigh Health Technologies
    Operator Number
    10090336
    Address
    200 Gate 5 Road, Suite 215
    City
    Sausalito
    State
    CA
    Postal Code
    94965
    Country
    US
    Correspondent
    Margaret McCabe

    Products

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

    Proprietary Names

    Celsi Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility