BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    OPTINA DIAGNOSTICS INC.

    Reg #: 3014606890 · FEI: 3014606890 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    OPTINA DIAGNOSTICS INC.
    Registration Number
    3014606890
    FEI Number
    3014606890
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    8200 Decarie Blvd, Suite #220
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K250770

    Owner / Operator

    Firm Name
    Optina Diagnostics
    Operator Number
    10081796
    Address
    8200 Decarie Blvd, Suite #220
    City
    Montreal
    State
    Quebec
    Postal Code
    H4P 2P5
    Country
    CA
    Correspondent
    Sarah Lemaire

    Products

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

    Proprietary Names

    Optina-4C Optina Fotys Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198