BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    MYAH

    Reg #: 3007913339 · FEI: 3007913399 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TOPCON EUROPE MEDICAL BV
    Registration Number
    3007913339
    FEI Number
    3007913399
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Essebaan 11, Capelle a/d IJssel
    City
    Capelle a/d IJssel Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K222933

    Owner / Operator

    Firm Name
    Topcon Europe Medical
    Operator Number
    10030334
    Address
    Essebaan 11, Capelle a/d IJssel
    City
    Capelle a/d IJssel
    State
    Zuid-Holland
    Postal Code
    2908 LJ
    Country
    NL

    US Agent

    Business Name
    Topcon Healthcare, Inc.
    Contact Name
    Susan Quick
    Address
    111 Bauer Dr
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US
    Email
    [email protected]
    Phone
    216 7605532

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Device, Analysis, Anterior Segment MXK

    Proprietary Names

    MYAH

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device