BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Harmony Referral System

    Reg #: 3014926240 · FEI: 3014926240 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Topcon Healthcare Solutions EMEA Oy
    Registration Number
    3014926240
    FEI Number
    3014926240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Saaristonkatu 9
    City
    OULU Pohjois-Pohjanmaa
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K210396

    Owner / Operator

    Firm Name
    Topcon Healthcare Solutions EMEA Oy
    Operator Number
    10058704
    Address
    Saaristonkatu 9
    City
    OULU
    State
    FI-NOTA
    Postal Code
    90100
    Country
    FI

    US Agent

    Business Name
    Topcon Healthcare, Inc.
    Contact Name
    Susan Quick
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    216 7805532

    Products

    Device Name Product Code
    System, Image Management, Ophthalmic NFJ

    Proprietary Names

    Harmony Referral System

    Establishment Types

    Manufacture Medical Device