BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Neitz Halogen Ophthalmoscope BXa-13

    Reg #: 8043512 · FEI: 3002807701 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NEITZ INSTRUMENTS COMPANY, LTD.
    Registration Number
    8043512
    FEI Number
    3002807701
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F ICHIBANCHO COURT, 15-21, ICHIBANCHO,
    City
    CHIYODA-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K942721

    Owner / Operator

    Firm Name
    NEITZ INSTRUMENTS CO.LTD.
    Operator Number
    9002089
    Address
    4F ICHIBANCHO COURT, 15-21, ICHIBANCHO
    City
    CHIYODA-KU
    State
    Tokyo
    Postal Code
    102-0082
    Country
    JP
    Correspondent
    Takashi Terui

    US Agent

    Business Name
    Qserve Group US, Inc.
    Contact Name
    Mindy McCann
    Address
    350 S. Main Street Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    Ophthalmoscope, Battery-Powered HLJ

    Proprietary Names

    Neitz Halogen Ophthalmoscope BXa-13 BXa-13, BXa-13A, BXa-RC, BXa13LED, BXa13ALED, BX?13RXLED, BX?13ARXLED, BX?13RXSPLED, BX?13ARXSPLED BXPlus-13, BXPlus-13A

    Establishment Types

    Manufacture Medical Device