BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Pure

    Reg #: 3014357822 · FEI: 3014357822 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIVANTOS SP. Z O.O.
    Registration Number
    3014357822
    FEI Number
    3014357822
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Przemyslowa 18
    City
    Komorniki
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K011366

    Owner / Operator

    Firm Name
    WSAUD A/S
    Operator Number
    10060087
    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
    185 Commerce Drive
    City
    Hauppauge
    State
    NY
    ZIP
    11788
    Country
    US
    Email
    [email protected]
    Phone
    561 7859321

    Products

    Device Name Product Code
    Masker, Tinnitus KLW

    Proprietary Names

    Pure Motion Vibe Pure Charge&Go Insio Charge&Go Silk Rexton Signia Active Styletto

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device