BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Sivantos GmbH

    Reg #: 3005019184 · FEI: 3005019184 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    43
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    Sivantos GmbH
    Registration Number
    3005019184
    FEI Number
    3005019184
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Henri-Dunant-Str. 100
    City
    Erlangen Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K011366

    Owner / Operator

    Firm Name
    WSAUD A/S
    Operator Number
    10023518
    Address
    Nymoellevej 6
    City
    Lynge
    State
    Hovedstaden
    Postal Code
    DK
    Country
    DK
    Correspondent
    Isabel Restivo

    US Agent

    Business Name
    WS Audiology USA, Inc.
    Contact Name
    Isabel Restivo
    Address
    101 Wood Avenue South, 7th Floor
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US
    Email
    [email protected]
    Phone
    551 5799581

    Products

    Device Name Product Code
    Audiometer EWO
    Masker, Tinnitus KLW
    Calibrator, Hearing Aid / Earphone And Analysis Systems ETW
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    CROS Motion Charge&Go Intuis Insio Charge&Go CROS AX Signia Pure Insio Insio IX Active Pro IX Intuis 3 Intuis 4 Silk Charge&Go Signia Motion Styletto AX Styletto Pure Charge&Go Unity 3 hearing instrument Unity 3 Unity 2 Unity 2 probe Miracle-Ear Pure Charge&Go AX Styletto IX Pure Charge&Go IX Motion Nx Rexton BiCore Signia AX Signia Intuis Signia X Rexton M-Core Signia IX Signia Insio Rexton Rexton Reach Signia Active Pro Signia Active SmartRIC Insio Nx Silk Charge&Go IX Connexx Motion Charge&Go IX CROS X Motion X

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device