BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    SpeediCath accessories

    Reg #: 3006405073 · FEI: 3006405073 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    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
    K180258

    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
    Catheter, Urethral GBM

    Proprietary Names

    SpeediCath accessories SpeediCath Standard SpeediCath Standard with Accessories

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)