BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Universal Trial Frame

    Reg #: 2518410 · FEI: 2518410 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    GULDEN OPHTHALMICS
    Registration Number
    2518410
    FEI Number
    2518410
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    225 CADWALADER AVE.
    City
    Elkins Park
    State
    PA
    ZIP
    19027
    Country
    US

    Owner / Operator

    Firm Name
    GULDEN OPHTHALMICS INC
    Operator Number
    2518410
    Address
    225 CADWALADER AVE., --
    City
    Elkins Park
    State
    PA
    Postal Code
    19027
    Country
    US
    Correspondent
    SEAN T COCKLEY

    Products

    Device Name Product Code
    Frame, Trial, Ophthalmic HPA

    Proprietary Names

    Universal Trial Frame Lens Holder without Scale Child Trial Frame Lens Holder Nose Bridge Raff Level Trial Flipper Lens Holder Handle Lens Holder Kit 8 Well Lens Holder with Scale Lens Holder Kit 4 Well Pediatric Trial Frame Premium Trial Frame Universal Lightweight Trial Frame

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device