BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    ICare Home Probe

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

    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
    K163343

    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

    Proprietary Names

    ICare Home Probe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)