BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DIOPSYS INC.

    Reg #: 3004174467 · FEI: 3004174467 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    DIOPSYS INC.
    Registration Number
    3004174467
    FEI Number
    3004174467
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1000 Kreider Drive, STE 700
    City
    Middletown
    State
    PA
    ZIP
    17057
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101763

    Owner / Operator

    Firm Name
    OpZira, Inc.
    Operator Number
    10093974
    Address
    1000 Kreider Drive, STE 700
    City
    Middletown
    State
    PA
    Postal Code
    17057
    Country
    US
    Correspondent
    Lori A Holder

    Products

    Device Name Product Code
    Stimulator, Photic, Evoked Response GWE

    Proprietary Names

    NOVA Vision Testing System

    Establishment Types

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