BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BDS E Sample Bag Set European - 400-03E

    Reg #: 1526534 · FEI: 1526534 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US, LLC
    Registration Number
    1526534
    FEI Number
    1526534
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    305 Enterprise Dr
    City
    Lewis Center
    State
    OH
    ZIP
    43035
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK070063

    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, Detection, Bacterial, For Platelet Transfusion Products MZC

    Proprietary Names

    BDS E Sample Bag Set European - 400-03E BDS E Sample Bag Set - 400-03 BDS E Sample Bag Set European 400-03E BDS 02 PROBE & GUARD FILTER 900-02 BDS E Sample Bag Set 400-03 400-03 sub-assembly 203206000 400-03E sub-assembly 203207000

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)