BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ErgoZoom

    Reg #: 3003848022 · FEI: 3003848022 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Metrex Research LLC
    Registration Number
    3003848022
    FEI Number
    3003848022
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6650 Ronald Reagan Ave
    City
    Madison
    State
    WI
    ZIP
    53704
    Country
    US

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1717 W. Collins Ave. Ca. 92867 USA, --
    City
    Orange
    State
    CA
    Postal Code
    92867
    Country
    US
    Correspondent
    Jennifer Evans

    Products

    Device Name Product Code
    Loupe, Diagnostic/Surgical FSP

    Proprietary Names

    ErgoZoom HDL 2.5 Micro HDL 3 HDL Prism 5.5 RDH Elite 2.5x EyeZoom HDL Prism 4.5 HDL 2.5 Macro OmniOptic EyeZoom Mini HDL Prism 3.5 EyeZoom Max HDL Ergo 3.5 Luxe 2.5 HDL Ergo 5 RDH Ergo 3x

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198