BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    iCare IC100

    Reg #: 3005324856 · FEI: 3005324856 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Icare Finland Oy
    Registration Number
    3005324856
    FEI Number
    3005324856
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ayritie 22
    City
    Vantaa Uusimaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K153694

    Owner / Operator

    Firm Name
    Icare Finland Oy
    Operator Number
    10022915
    Address
    Icare Finland Oy, Ayritie 22
    City
    Vantaa
    State
    Uusimaa
    Postal Code
    01510
    Country
    FI
    Correspondent
    Hannes Hyvonen

    Products

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

    Proprietary Names

    iCare IC100

    Establishment Types

    Manufacture Medical Device