BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Provox FreeHands FlexiVoice Set

    Reg #: 8032044 · FEI: 3002806269 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    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
    K141380

    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

    Provox FreeHands FlexiVoice Set Provox FreeHands FlexiVoice Strong Provox FreeHands FlexiVoice Set Plus Provox FreeHands FlexiVoice Medium Provox FreeHands HME Flow Provox FreeHands FlexiVoice Light Provox FreeHands HME Moist Provox FreeHands FlexiVoice Arch Provox FreeHands FlexiVoice XtraStrong Provox Life FreeHands FlexiVoice Set Plus

    Establishment Types

    Manufacture Medical Device