BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    GKC MANUFACTURING PTY LTD

    Reg #: 3011196543 · FEI: 3011196543 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GKC MANUFACTURING PTY LTD
    Registration Number
    3011196543
    FEI Number
    3011196543
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Level 9, 31 Queen Street
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K140086

    Owner / Operator

    Firm Name
    Empatica S.r.l.
    Operator Number
    10047497
    Address
    Via Stendhal, 36
    City
    Milan
    State
    Milano
    Postal Code
    20144
    Country
    IT
    Correspondent
    Alberto Poli

    US Agent

    Business Name
    Empatica Inc.
    Contact Name
    Matteo Lai
    Address
    1 Broadway Ste 14
    City
    Cambridge
    State
    MA
    ZIP
    02142
    Country
    US
    Email
    [email protected]
    Phone
    415 5483860

    Products

    Device Name Product Code
    Transducer, Tremor GYD
    Reminder, Medication NXQ
    Exerciser, Measuring ISD

    Proprietary Names

    Personal KinetiGraph (PKG) System PKG Personal Kinetigraph System Personal Kinetigraph System Gen 2 Plus

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device