BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Translux Wave

    Reg #: 3005665377 · FEI: 3005665377 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    KULZER GMBH
    Registration Number
    3005665377
    FEI Number
    3005665377
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Leipziger StraBe 2
    City
    HANAU Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K042199

    Owner / Operator

    Firm Name
    KULZER, LLC
    Operator Number
    9056636
    Address
    4315 S. Lafayette Blvd.
    City
    South Bend
    State
    IN
    Postal Code
    46614
    Country
    US

    US Agent

    Business Name
    Kulzer, LLC
    Contact Name
    David Vincent
    Address
    4315 S Lafayette Blvd
    City
    South Bend
    State
    IN
    ZIP
    46614
    Country
    US
    Email
    [email protected]
    Phone
    574 2995421

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ

    Proprietary Names

    Translux Wave Translux 2 Wave TRANSLUX POWER BLUE

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device