BEUDAMED
    FDA Registration Active 🇨🇳 China

    Therasteam Personal Steam Inhaler

    Reg #: 3004871905 · FEI: 3004871905 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    62
    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
    K950116

    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
    Humidifier, Non-Direct Patient Interface (Home-Use) KFZ

    Proprietary Names

    Therasteam Personal Steam Inhaler HEV355T QuietCare® Cool Moisture Humidifier HEV312 Cool Moisture Humidifier HEV320BT Cool Moisture Humidifier HWM-340W Easy to Care Top Fill Warm Mist Humidifier HCM-710 Easy to Care Top Fill Cool Moisture Humidifier HUT-220W Easy to Care Filter Free Humidifier HUL520RV1 MistMate ™ Cool Mist Humidifier HWM705BTD1 Warm Mist Humidifier HUL520R MistMate ™ Cool Mist Humidifier HEV355 QuietCare® Cool Moisture Humidifier HWM-340B Easy to Care Top Fill Warm Mist Humidifier HCM-750B Easy to Care Top Fill Cool Moisture Humidifier HCM-750 Easy to Care Top Fill Cool Moisture Humidifier HCM-890 Cool Moisture Humidifier HWM340BTD1 Top Fill Warm Mist Humidifier HEV680W Easy to Care Top Fill Cool Moisture Humidifier HCM-6011GQuietCare® Cool Moisture Humidifier HUT-220B Easy to Care Filter Free Humidifier HWM705B Warm Mist Humidifier HUL520WV1 MistMate ™ Cool Mist Humidifier HCM-350 UltraViolet Germ-Free Humidification HCM315TTD1 UltraViolet Germ-Free Humidification HEV320W Cool Moisture Humidifier HCM-315T UltraViolet Germ-Free Cool Moisture Humidifier HCM-300T UltraViolet Germ-Free Cool Mist Humidifier HUL520LV1 MistMate ™ Cool Mist Humidifier HUL520W MistMate ™ Cool Mist Humidifier HUT-300B Filter Free Cool Mist Humidifier HUL535WTD1 Ultrasonic Cool Mist Humidifier HUL535B Ultrasonic Cool Mist Humidifier HCM-750NWMT Easy to Care Top Fill Cool Moisture Humidifier HUL535W Ultrasonic Cool Mist Humidifier HUL520B MistMate ™ Cool Mist Humidifier HUL520BV1 MistMate ™ Cool Mist Humidifier HEV320B Cool Moisture Humidifier HUT300BTD1 Filter Free Cool Moisture Humidifier HWM-340WWMT Easy to Care Top Fill Warm Mist Humidifier HEV680B Easy to Care Top Fill Cool Moisture Humidifier HUT220BTD1 Top Fill Ultrasonic Humidifier HCM-350B UltraViolet Germ-Free Humidification HCM-6009 QuietCare® Cool Moisture Humidifier HCM-890B Cool Moisture Humidifier HUL520L MistMate ™ Cool Mist Humidifier HUL570B Honeywell Easy to Care Cool Mist Humidifier HEV685B Honeywell Easy to Care Top Fill Cool Moisture Humidifier CVS Health Warm Steam Vaporizer GVP110 HUL233 VUL600 HUL430 HEV615 Honeywell Easy to Care Cool Moisture Humidifier VUL530 Vicks NaturalCare Humidifier Diffuser VapoPads Nitetime-Light LUL520 Rite Aid Ultasonic Cool Mist Humidifier HUL570BV2 Honeywell Easy to Care Cool Mist Humidifier VUL500 Vicks 3-in-1 SleepyTime Humidifier VUL525 Vicks Mini FilterFree Cool Mist Humidifier CVS Health Cool Mist Humidifier GUL540 HUL900B Honeywell Reflection Cool Mist Filter Free Humidifier LUL535 Rite Aid Ultasonic Cool Mist Humidifier HEV620 Honeywell Easy to Care Cool Moisture Humidifier CVS Health Warm Mist Humidifier GWM700 VUL530V1 Vicks NaturalCare Humidifier Diffuser VapoPads Nitetime-Light

    Establishment Types

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