BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Signia Siemens Pure 13 BT

    Reg #: 3005019184 · FEI: 3005019184 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    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
    K011366

    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
    Masker, Tinnitus KLW

    Proprietary Names

    Signia Siemens Pure 13 BT Rexton Motif Rexton Legato Rexton Inox Siemens Sirion Signia Siemens Silk Rexton Stellar Rexton Voyage Rexton CROS Rexton Accord Rexton Finesse Rexton Sterling Rexton Onyx Signia Siemens Intuis Rexton Trax Rexton Quintra Signia Siemens Motion Signia Siemens Pure Siemens Intuis Siemens Orion Signia Siemens CROS Pure Siemens Nitro Signia Siemens Insio Signia Siemens Carat Siemens Motion Rexton Emerald Rexton Joy Rexton Mosaic Signia Siemens Cellion

    Establishment Types

    Manufacture Medical Device