BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Provox2 Voice Prosthesis

    Reg #: 8032044 · FEI: 3002806269 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ATOS MEDICAL AB
    Registration Number
    8032044
    FEI Number
    3002806269
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    KRAFTGATAN 8
    City
    HORBY Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K971244

    Owner / Operator

    Firm Name
    ATOS MEDICAL AB
    Operator Number
    8032044
    Address
    KRAFTGATAN 8, --
    City
    HORBY
    State
    SE-NOTA
    Postal Code
    SE-24235
    Country
    SE
    Correspondent
    Karolina - Nilsson

    Products

    Device Name Product Code
    Prosthesis, Laryngeal (Taub) EWL

    Proprietary Names

    Provox2 Voice Prosthesis

    Establishment Types

    Manufacture Medical Device