BEUDAMED
    FDA Registration Active 🇨🇳 China

    ArcScan Insight 100

    Reg #: 3008132411 · FEI: 3008132411 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Shanghai E Beam Ltd.
    Registration Number
    3008132411
    FEI Number
    3008132411
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    A603 Lane 108, No. 588, Chuantu Road, ChuanSha, Pudong
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K153416

    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, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    ArcScan Insight 100 ED3 EyeSeal

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)