BEUDAMED
    FDA Registration Active 🇨🇳 China

    IRT-3030

    Reg #: 3004871905 · FEI: 3004871905 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Helen of Troy Macao Limited
    Registration Number
    3004871905
    FEI Number
    3004871905
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Xian Xing Hai No. 105, Centro Golden Dragon, 14 Andar H,I,J,K
    City
    Macau Guangdong
    Country
    CN

    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

    US Agent

    Business Name
    Kaz USA, Inc., A Helen of Troy Company
    Contact Name
    Sonja Wilkinson
    Address
    400 DONALD LYNCH BOULEVARD SUITE 300
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    508 4907236

    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

    Export Device to the United States But Perform No Other Operation on Device