BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Neuro-Eye Diagnostic Systems, LLC

    Reg #: 3042954736 · FEI: 3042954736 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Neuro-Eye Diagnostic Systems, LLC
    Registration Number
    3042954736
    FEI Number
    3042954736
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2020 Quenby St
    City
    Houston
    State
    TX
    ZIP
    77005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203594

    Owner / Operator

    Firm Name
    Neuro-Eye Diagnostic Systems, LLC
    Operator Number
    10094829
    Address
    2020 Quenby Street
    City
    Houston
    State
    TX
    Postal Code
    77005
    Country
    US
    Correspondent
    Jade S Schiffman

    Products

    Device Name Product Code
    Digital Amsler Grid QTW

    Proprietary Names

    EyeCTester Monitoring App

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility