BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    iCare; iCare tonometer

    Reg #: 3010287677 · FEI: 3010287677 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MARIACHI OY
    Registration Number
    3010287677
    FEI Number
    3010287677
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kaarinantie 700
    City
    Littoinen Varsinais-Suomi
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K063873

    Owner / Operator

    Firm Name
    Mariachi Oy
    Operator Number
    10043088
    Address
    Kaarinantie 700
    City
    Littoinen
    State
    Varsinais-Suomi
    Postal Code
    20660
    Country
    FI
    Correspondent
    Pasi Hatakka

    Products

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

    Proprietary Names

    iCare; iCare tonometer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)