BEUDAMED
    FDA Registration Active 🇫🇷 France

    Fertiloscopy F42K Kit FH 1.29 / FTO 1.40.

    Reg #: 3007156625 · FEI: 3008133910 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    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
    K992655

    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
    Laparoscope, Gynecologic (And Accessories) HET
    Hysteroscope (And Accessories) HIH
    Culdoscope (And Accessories) HEW

    Proprietary Names

    Fertiloscopy F42K Kit FH 1.29 / FTO 1.40.

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)