BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Icare Tonometer Probes, TP01s

    Reg #: 3004681519 · FEI: 3003870583 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Belgium Fleurus SA
    Registration Number
    3004681519
    FEI Number
    3003870583
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Zoning Industrial de Fleurus, Avenue De L Esperance, 17
    City
    Fleurus Hainaut
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K063873

    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
    Tonometer, Manual HKY
    Tonometer, Ac-Powered HKX

    Proprietary Names

    Icare Tonometer Probes, TP01s

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)