BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Follicle Aspiration Set, Reduced

    Reg #: 3006405073 · FEI: 3006405073 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics Denmark A/S
    Registration Number
    3006405073
    FEI Number
    3006405073
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Aa Louis - Hansens Alle 11
    City
    Espergaerde Sjalland
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K172050

    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
    Needle, Assisted Reproduction MQE

    Proprietary Names

    Follicle Aspiration Set, Reduced Follicle Aspiration Set, Reduced Single Lumen

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)