BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    7GA EnCor

    Reg #: 3004681601 · FEI: 3004681601 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Thailand Ltd.
    Registration Number
    3004681601
    FEI Number
    3004681601
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    109/16 Eastern Seaboard Industrial Estate Moo 4, Tambol Pluak Daeng, Amphur Pluak Daeng
    City
    Rayong Province
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K051158

    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
    Instrument, Biopsy KNW

    Proprietary Names

    7GA EnCor 7GA EnCor Upright 12GA EnCor EnCor /VisilocMRI Introducer 7GA EnCor MRI 12GA EnCor Probe Upright

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)