BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    EmbracePlus

    Reg #: 3012933969 · FEI: 3012933969 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    EMPATICA S.r.l.
    Registration Number
    3012933969
    FEI Number
    3012933969
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Enrico Stendhal 36
    City
    Milano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K230457

    Owner / Operator

    Firm Name
    Empatica
    Operator Number
    10058838
    Address
    Via Stendhal 36
    City
    Milan
    State
    Lombardy
    Postal Code
    20144
    Country
    IT
    Correspondent
    Alberto Poli

    US Agent

    Business Name
    Empatica Inc
    Contact Name
    Matteo Lai
    Address
    1 Broadway
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    415 5483860

    Products

    Device Name Product Code
    Device, Galvanic Skin Response Measurement GZO
    Monitor, Breathing Frequency BZQ
    Device, Sleep Assessment LEL
    Oximeter DQA
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Continuous Measurement Thermometer FLL

    Proprietary Names

    EmbracePlus Empatica Health Monitoring Platform Care Portal Empatica Care

    Establishment Types

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