BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    DRI OCT Triton (plus)

    Reg #: 3008729548 · FEI: 3008729548 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Topcon Yamagata Co., LTD
    Registration Number
    3008729548
    FEI Number
    3008729548
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    547 aza Ishida Oaza Urushiyama Yamagata-SHI
    City
    Yamagata-KEN
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K173119

    Owner / Operator

    Firm Name
    Topcon Healthcare, Inc.
    Operator Number
    9031569
    Address
    111 Bauer Drive
    City
    Oakland
    State
    NJ
    Postal Code
    07436
    Country
    US

    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
    Camera, Ophthalmic, Ac-Powered HKI
    Tomography, Optical Coherence OBO

    Proprietary Names

    DRI OCT Triton (plus) DRI OCT Triton

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)