BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Canon Medical Diagnostics USA, Inc.

    Reg #: 2936856 · FEI: 2936856 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    Canon Medical Diagnostics USA, Inc.
    Registration Number
    2936856
    FEI Number
    2936856
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    630 Clyde Ct
    City
    MOUNTAIN VIEW
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K112910

    Owner / Operator

    Firm Name
    Canon Medical Diagnostics USA, Inc.
    Operator Number
    2936856
    Address
    630 CLYDE CT., --
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US

    Products

    Device Name Product Code
    System, Test, Radioallergosorbent (Rast) Immunological DHB
    Ige, Antigen, Antiserum, Control DGC
    System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens PUW

    Proprietary Names

    AP 720S Semi-Automated Instrument CLA-1 Luminometer CLA Allergen Specific IgE Assay OPTIGEN Allergen Specific IgE Assay OPTIGEN US Food 16 OPTIGEN US Panel Control Reagent Kit OPTIGEN US Inhalant 36 OPTIGEN US Mix 36 OPTIGEN US Food 20 OPTIGEN US Food 25 OPTIGEN US Environmental 36 (100ND) OPTIGEN Environmental 36 (20T) OPTIGEN US Food 30 (100 ND) OPTIGEN Food 29 (20T) OPTIGEN Southern Express Panel I (40ND) OPTIGEN Food 20 OPTIGEN Korean Food OPTIGEN Alimenticio OPTIGEN Mix 30 OPTIGEN Inhalant 20 OPTIGEN Food 30 OPTIGEN Inhalant 36 #1 OPTIGEN Inhalant 30 OPTIGEN Korean Inhalant OPTIGEN Inhalatorio OPTIGEN Universal Panel 36 (Taiwan Panel) OPTIGEN ASEAN AP3600 Automated Instrument CLA positive control sera CLA negative control sera

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only