BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    B4C System - Wireless Sensor External Battery (Model: BcSs-BAT-1000 or BcSs-BATEX-1000)

    Reg #: 3017180827 · FEI: 3017180827 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BRAINCARE DESENVOLVIMENTO E INOVACAO TECNOLOGICA S.A.
    Registration Number
    3017180827
    FEI Number
    3017180827
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Av Bruno Ruggiero Filho, 971
    City
    Sao Carlos Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K201989

    Owner / Operator

    Firm Name
    Braincare Desenvolvimento e Inovacao Tecnologica S.A.
    Operator Number
    10061705
    Address
    Av Bruno Ruggiero Filho, 971
    City
    São Carlos
    State
    Sao Paulo
    Postal Code
    13562-420
    Country
    BR
    Correspondent
    Arnaldo Betta

    US Agent

    Business Name
    Braincare USA Corp
    Contact Name
    Claudio Menegusso
    Address
    6470 E Johns Xing Ste 160 Ofc 114
    City
    Johns Creek
    State
    GA
    ZIP
    30097
    Country
    US
    Email
    [email protected]
    Phone
    424 8882942

    Products

    Device Name Product Code
    Device, Monitoring, Intracranial Pressure GWM

    Proprietary Names

    B4C System - Wireless Sensor External Battery (Model: BcSs-BAT-1000 or BcSs-BATEX-1000) B4C System - Wireless Sensor (Model: BCSs-PICNIW-1000) B4C System - Wireless Sensor Charger (Model: BcAc-DCK-1000) B4C System B4C System - Wireless Adapter (Model: BcAc-DG-1000) B4C System - Wireless Sensor Headband Set (Model: BcAc-AF-1000) B4C System - Wireless Sensor Headband Set (Model: BcAc-FU-1000) B4C System - Plastic casing (Model: BcAc-CASE-1000)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device