BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Bittium Faros 360 waterproof

    Reg #: 1000425315 · FEI: 1000425315 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Bittium Biosignals Ltd.
    Registration Number
    1000425315
    FEI Number
    1000425315
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PIONEERINKATU 6
    City
    KUOPIO Pohjois-Savo
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K182030

    Owner / Operator

    Firm Name
    Bittium Biosignals Ltd.
    Operator Number
    9027486
    Address
    Pioneerinkatu 6, --
    City
    KUOPIO
    State
    Pohjois-Savo
    Postal Code
    70800
    Country
    FI
    Correspondent
    Aliina - Nieminen

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Detector And Alarm, Arrhythmia DSI
    Electrocardiograph, Ambulatory, With Analysis Algorithm MLO
    Transmitters And Receivers, Electrocardiograph, Telephone DXH

    Proprietary Names

    Bittium Faros 360 waterproof Bittium Cardiac Explorer Bittium Faros 180 waterproof Bittium Cardiac Navigator Faros Mobile Faros14d

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device