BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Siberian Fit

    Reg #: 3007085226 · FEI: 3007085226 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Vydence Medical Industria e Comercio Ltda
    Registration Number
    3007085226
    FEI Number
    3007085226
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rua Aldo Germano Klein, 359, CEP: 13.573-470 - Caixa Postal 772
    City
    CEAT - Sao Carlos/SP Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K172439

    Owner / Operator

    Firm Name
    Vydence Medical Industria e Comercio Ltda
    Operator Number
    10040501
    Address
    Rua Aldo Germano Klein, 359, CEP: 13.573-470 - Caixa Postal 772
    City
    CEAT - Sao Carlos
    State
    Sao Paulo
    Postal Code
    34446
    Country
    BR
    Correspondent
    Eduardo Alves Gabriel

    US Agent

    Business Name
    Hoy & Associates Regulatory Consulting LLC
    Contact Name
    Connie Hoy
    Address
    1830 Bonnie Way
    City
    Sacramento
    State
    CA
    ZIP
    95825
    Country
    US
    Email
    [email protected]
    Phone
    530 9084903

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Siberian Fit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device