BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    Topcon Healthcare Solutions EMEA Oy

    Reg #: 3014926240 · FEI: 3014926240 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Topcon Healthcare Solutions EMEA Oy
    Registration Number
    3014926240
    FEI Number
    3014926240
    Status
    Active
    Expiry Year
    2026
    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
    Medical Device Data System OUG
    Refractometer, Ophthalmic HKO
    System, Image Management, Ophthalmic NFJ

    Proprietary Names

    RDx Harmony Plus Harmony Referral System Optoflow Harmony One

    Establishment Types

    Manufacture Medical Device