BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Enlight 2100

    Reg #: 3016509761 · FEI: 3016509761 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TIMPEL S.A.
    Registration Number
    3016509761
    FEI Number
    3016509761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Jose Leonardi 280 Bloco A
    City
    Pato Branco Parana
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K222897

    Owner / Operator

    Firm Name
    TIMPEL S.A.
    Operator Number
    10062190
    Address
    Rua Jose Leonardi 280 Bloco A
    City
    Pato Branco
    State
    Parana
    Postal Code
    85503
    Country
    BR
    Correspondent
    Rafael Holzhacker

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matthew Dryden
    Address
    131 Bay Point Dr NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Ventilatory Electrical Impedance Tomograph QEB

    Proprietary Names

    Enlight 2100

    Establishment Types

    Manufacture Medical Device