BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    OrthoPulse

    Reg #: 3017271131 · FEI: 3017271131 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOLUX TECHNOLOGY GMBH
    Registration Number
    3017271131
    FEI Number
    3017271131
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Neubaugasse 31
    City
    Absdorf Niederosterreich
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K143120

    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
    Sigma Scientific Services
    Contact Name
    Jorge Millan
    Address
    490 Sawgrass Corporate Pkwy Ste 130
    City
    Sunrise
    State
    FL
    ZIP
    33325
    Country
    US
    Email
    [email protected]
    Phone
    786 4165587

    Products

    Device Name Product Code
    Orthodontic Led Accessory PLH

    Proprietary Names

    OrthoPulse OrthoPulse - Standard - Gen 2

    Establishment Types

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