BEUDAMED
    FDA Registration Active 🇨🇳 China

    CA15L1 EmprintTM Short Percutaneous Antenna with ThermosphereTM Technology

    Reg #: 3007007790 · FEI: 3007007790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Shanghai ETO Ltd.
    Registration Number
    3007007790
    FEI Number
    3007007790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 333, Shuang Hui Road, Yang Shan Free Port
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K133821

    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
    System, Ablation, Microwave And Accessories NEY

    Proprietary Names

    CA15L1 EmprintTM Short Percutaneous Antenna with ThermosphereTM Technology CA30L1 EmprintTM long Percutaneous Antenna with ThermosphereTM Technology CA20L1 EmprintTM Standard Percutaneous Antenna with ThermosphereTM Technology Emprint™ Short Percutaneous Antenna with Thermosphere™ Technology, CA15L1/CA15L2 Emprint™ Long Percutaneous Antenna with Thermosphere™ Technology, CA30L1/CA30L2 Emprint™ Standard Percutaneous Antenna with Thermosphere™ Technology, CA20L1/CA20L2

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)