BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    iCare ST500 (TA04)

    Reg #: 3009496855 · FEI: 3009496855 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    VALUKUMPU OY
    Registration Number
    3009496855
    FEI Number
    3009496855
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Raivaajantie 1
    City
    Joensuu Pohjois-Karjala
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K241447

    Owner / Operator

    Firm Name
    Valukumpu Oy
    Operator Number
    10038905
    Address
    Raivaajantie 1
    City
    Joensuu
    State
    Pohjois-Karjala
    Postal Code
    80100
    Country
    FI
    Correspondent
    Elli Majoinen

    Products

    Device Name Product Code
    Tonometer, Manual HKY
    Tonometer, Ac-Powered HKX

    Proprietary Names

    iCare ST500 (TA04)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)