BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Ocu-Film® + Tip Covers

    Reg #: 9616517 · FEI: 3003117688 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics S. de R.L. de C.V.
    Registration Number
    9616517
    FEI Number
    3003117688
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Parque Industrial Tepeji, Calle North 7 s/n
    City
    Tepeji del Rio de Ocampos Hidalgo
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K070534

    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
    Tonometer, Manual HKY

    Proprietary Names

    Ocu-Film® + Tip Covers

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)