BEUDAMED
    FDA Registration Active 🇫🇷 France

    Celsite (REF 05433734)

    Reg #: 3007156625 · FEI: 3008133910 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics SAS
    Registration Number
    3007156625
    FEI Number
    3008133910
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Rue Parmentier
    City
    Rantigny Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K130576

    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
    Port & Catheter, Implanted, Subcutaneous, Intravascular LJT

    Proprietary Names

    Celsite (REF 05433734) Celsite (REF 05430095, 05430425, 05432460, 05433556, 05433750, 05433823, 05436709, 05436717, 05436725, 05436946) Celsite Concept (REF 05437025, 05437026, 05437028) Celsite (REF 05430100, 05430101) Celsite Discreet (REF 05430144, 05430145, 05430146) Celsite Babyport (REF 05433742) / Celsite Babyport S (REF 05433842)

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)