BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Fast-Fix ECG Electrode

    Reg #: 1000425315 · FEI: 1000425315 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    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

    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
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Fast-Fix ECG Electrode BodyGuardian MINI Strip Bittium OmegaSnap 2-CH ECG Electrode Bittium OmegaSnap 3-CH ECG Electrode Bittium OmegaSnap 1-CH Adapter Bittium OmegaSnap Multi-CH Adapter Bittium OmegaSnap 1-CH ECG Electrode Bittium MiniSnap Sensitive 1-CH ECG Electrode

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198