BEUDAMED
    FDA Registration Active 🇭🇺 Hungary

    WR19

    Reg #: 3017970307 · FEI: 3017970307 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Zeto EU Kft.
    Registration Number
    3017970307
    FEI Number
    3017970307
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Back Bernat utca 6. Tender Office Irodahaz 2. emelet
    City
    Szeged Csongrad
    Country
    HU

    Regulatory Submissions

    510(k) Number
    K172735

    Owner / Operator

    Firm Name
    Zeto, Inc.
    Operator Number
    10057738
    Address
    4701 Patrick Henry Dr, Bldg #25
    City
    Santa Clara
    State
    CA
    Postal Code
    95054
    Country
    US
    Correspondent
    Aswin Gunasekar

    US Agent

    Business Name
    ZETO, INC.
    Contact Name
    Aswin Gunasekar
    Address
    4701 Patrick Henry Dr, Bldg #25
    City
    Santa Clara
    State
    CA
    ZIP
    95054
    Country
    US
    Email
    [email protected]
    Phone
    833 9386334

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY
    Full-Montage Standard Electroencephalograph GWQ

    Proprietary Names

    WR19

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device