BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IRT-3030

    Reg #: 3006169981 · FEI: 3006169981 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Kaz USA, Inc., A Helen of Troy Company
    Registration Number
    3006169981
    FEI Number
    3006169981
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    400 DONALD LYNCH BOULEVARD SUITE 300
    City
    MARLBOROUGH
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161933

    Owner / Operator

    Firm Name
    Kaz USA, Inc., A Helen of Troy Company
    Operator Number
    1314800
    Address
    400 Donald Lynch Boulevard, Suite 300
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sonja Wilkinson

    Products

    Device Name Product Code
    Continuous Measurement Thermometer FLL

    Proprietary Names

    IRT-3030 Braun IRT-3030US IRT-3515US IRT3030LA IRT-3515 Braun ThermoScan® 4 Ear Thermometer IRT3515 Braun ThermoScan® 4 Ear Thermometer IRT3515US Braun ThermoScan IRT3030USV1 Braun ThermoScan 4 Ear Thermometer IRT3515CSUS Braun ThermoScan 4 Ear Thermometer IRT3515USV1 BRAUN ThermoScan 4+ connect Ear thermometer IRT3575US

    Establishment Types

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