BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    UNIDADE DE ESTERILIZACAO COTIA LTDA.

    Reg #: 3005914490 · FEI: 3005914490 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UNIDADE DE ESTERILIZACAO COTIA LTDA.
    Registration Number
    3005914490
    FEI Number
    3005914490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Av. Cruzada Bandeirantes/ N 29 0
    City
    Cotia Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K133510

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)