BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Digital Retinal Camera CR-2 Plus AF

    Reg #: 3038614464 · FEI: 3038614464 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Canon.Inc
    Registration Number
    3038614464
    FEI Number
    3038614464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30-2, SHIMOMARUKO 3-CHOME,
    City
    OHTA-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K201122

    Owner / Operator

    Firm Name
    CANON INC.
    Operator Number
    8030410
    Address
    30-2 SHIMOMARUKO, 3-CHOME,
    City
    OHTA-KU
    State
    Tokyo
    Postal Code
    146-8501
    Country
    JP

    US Agent

    Business Name
    Canon Medical Components U.S.A., Inc.
    Contact Name
    John CORWIN
    Address
    2355 Main St Ste 150
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 2412582

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    System, Image Management, Ophthalmic NFJ

    Proprietary Names

    Digital Retinal Camera CR-2 Plus AF Digital Retinal Camera CR-2 AF

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility