BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CRE-C20

    Reg #: 3005019184 · FEI: 3005019184 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K233464

    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
    Self-Fitting Air-Conduction Hearing Aid, Prescription QDD
    Self-Fitting Air-Conduction Hearing Aid, Over The Counter QUH

    Proprietary Names

    CRE-C20

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility