BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    BIOLUX TECHNOLOGY GMBH

    Reg #: 3017271131 · FEI: 3017271131 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOLUX TECHNOLOGY GMBH
    Registration Number
    3017271131
    FEI Number
    3017271131
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Neubaugasse 31
    City
    Absdorf Niederosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K230905

    Owner / Operator

    Firm Name
    Biolux Technology GmbH
    Operator Number
    10049976
    Address
    Neubaugasse 31
    City
    Absdorf
    State
    AT-NOTA
    Postal Code
    3462
    Country
    AT

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street Suite 103
    City
    Miami
    State
    FL
    ZIP
    33125
    Country
    US
    Email
    [email protected]
    Phone
    305 5999373

    Products

    Device Name Product Code
    Orthodontic Led Accessory PLH

    Proprietary Names

    OrthoPulse - Extended - Gen 2 OrthoPulse OrthoPulse - Standard - Gen 2 OrthoPulse Lite

    Establishment Types

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