BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Siemens Unity 3 hearing instrument analyzer

    Reg #: 3005019184 · FEI: 3005019184 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sivantos GmbH
    Registration Number
    3005019184
    FEI Number
    3005019184
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Henri-Dunant-Str. 100
    City
    Erlangen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K071462

    Owner / Operator

    Firm Name
    WSAUD A/S
    Operator Number
    10023518
    Address
    Nymoellevej 6
    City
    Lynge
    State
    Hovedstaden
    Postal Code
    DK-3540
    Country
    DK
    Correspondent
    La-Shaunda Joseph

    US Agent

    Business Name
    WS Audiology USA, Inc.
    Contact Name
    La-Shaunda Joseph
    Address
    101 Wood Avenue South, 7th Floor
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US
    Email
    [email protected]
    Phone
    561 7859321

    Products

    Device Name Product Code
    Calibrator, Hearing Aid / Earphone And Analysis Systems ETW

    Proprietary Names

    Siemens Unity 3 hearing instrument analyzer Siemens Unity 3 probe (REM) Siemens Unity 2 hearing instrument analyser Siemens Unity 2 probe (REM)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility