BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Synergy ODM

    Reg #: 2242863 · FEI: 2242863 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Topcon Healthcare, Inc.
    Registration Number
    2242863
    FEI Number
    2242863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    111 Bauer Dr
    City
    Oakland
    State
    NJ
    ZIP
    07436
    Country
    US

    Regulatory Submissions

    510(k) Number
    K151952

    Owner / Operator

    Firm Name
    Topcon Healthcare, Inc.
    Operator Number
    2242863
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    Postal Code
    07436
    Country
    US

    Products

    Device Name Product Code
    System, Image Management, Ophthalmic NFJ

    Proprietary Names

    Synergy ODM

    Establishment Types

    Manufacture Medical Device