Helen of Troy Macao Limited

FDA Device Registration & Listing · Macau Guangdong, CN · Registration 3004871905

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004871905
FEI Number
3004871905
Entity Name
Helen of Troy Macao Limited
City/State/Country
Macau Guangdong, CN
Establishment Address
Avenida Xian Xing Hai No. 105, Centro Golden Dragon, 14 Andar H,I,J,K, Macau Guangdong 999078, CN
Establishment Type(s)
Foreign Private Label Distributor
Owner / Operator
Kaz USA, Inc., A Helen of Troy Company (Owner Number: 1314800)
Owner / Operator Contact Address
400 Donald Lynch Boulevard, Suite 300, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VICKS NO TOUCH THERMOMETER BRAUN NO TOUCH THERMOMETER Braun® Nasal Aspirator BRAUN ExactFit™ 2 connect Upper arm Blood pressure monitor Vicks Underarm Thermometer Vicks Braun Thermoscan Braun Thermoscan Vicks Braun Braun ThermoScan Braun ThermoScan 4 Ear Thermometer BRAUN ThermoScan 4+ connect Ear thermometer Braun ThermoScan Lens Filters LF40 and LF20 Hantech Probe Cover LF40 and LF20 Honeywell Vicks Braun Dunlap Soft Heat Bruder VICKS NON CONTACT INFRARED BODY THERMOMETER Braun Thermoscan PRO 4000 series Braun Thermoscan IRT 4000 series Braun Thermoscan Smart Temp Mind + Body Care Vicks SoftHest BRAUN ExactFit™ 1 Upper arm blood pressure monitor Honeywell BRAUN EXACTFIT 3 UPPER ARM BLOOD PRESSURE MONITOR BRAUN Vicks Braun Thermoscan Vicks, Instant Digital Electric Thermometer Vick ComfortFlex Thermometer Vicks Digital Thermometer Braun Digital Thermometer Therasteam Personal Steam Inhaler QuietCare® Cool Moisture Humidifier Easy to Care Top Fill Warm Mist Humidifier Top Fill Ultrasonic Humidifier Filter Free Cool Moisture Humidifier Ultrasonic Cool Mist Humidifier Warm Mist Humidifier UltraViolet Germ-Free Humidification UltraViolet Germ-Free Cool Moisture Humidifier Top Fill Warm Mist Humidifier MistMate™ Cool Mist Humidifier Easy to Care Filter Free Humidifier Cool Moisture Humidifier Filter Free Cool Mist Humidifier UltraViolet Germ-Free Cool Mist Humidifier Easy to Care Top Fill Cool Moisture Humidifier CVS Health Warm Mist Humidifier Rite Aid Ultasonic Cool Mist Humidifier Honeywell Easy to Care Cool Moisture Humidifier Vicks NaturalCare Humidifier Diffuser VapoPads Nitetime-Light CVS Health Cool Mist Humidifier Honeywell Easy to Care Cool Mist Humidifier CVS Health Warm Steam Vaporizer Vicks Mini FilterFree Cool Mist Humidifier Vicks 3-in-1 SleepyTime Humidifier Honeywell Reflection Cool Mist Filter Free Humidifier Kaz Vicks Vicks RapidRead Digital Thermometer Braun ThermoScan 3 High Speed Compact Ear Thermometer Braun Infrared Forehead Thermometer Vicks Pacifier Braun Braun Braun Precision Sensor Vicks Cordless Steam Inhaler Kaz Walgreens Protec Vicks CVS ProCare Rite Aid Walgreens Cool Mist Humidifier FilterFree Plus Cool Mist Humidifier Vicks Warm Mist Humidifier Vicks Embrace Cool Mist Filter Free Humidifier Honeywell Dual Comfort Humidifier Vicks Dual Comfort Cool + Warm Filter Free Humidifier Vicks FilterFree Cool Mist Humidifier CVS Health Warm Mist Humidifier CVS Health Steam Inhaler Vicks VapoPads Refill Pads Vicks VapoPads PLUS Vicks VapoPads Refills Vicks VapoPads CVS Health Inhalant Pad Refills HONEYWELL Vicks VapoPads SINUS Vicks Filtered Cool Mist Humidifier Vicks Sleepy Time Vapopads Vicks Sinus Steam Inhaler Vicks VapoPads Calming Vapors Thermometer Thermometer with Charge Dock Braun Probe Covers Welch Allyn Thermometer Charge Dock Only 9' Tether for PRO6000 Therm w/ small cradle 4th Ed Rechargeable Battery PRO6000 6' Tether for PRO 6000 PRO6000 w/Small Cradle & Charging Dock Braun Thermoscan Pro 6000 Pro6000 Bulk Pack 4th ed Therm w/ large cradle 4th ed PRO6000 Large Cradle PRO6000 Small Cradle PRO6000 Bulk Pack PRO6000 Charge Station (US) PRO6000 Charge Station PRO 6000 CHARGE DOCK Therm w/ small cradle Them w/ large cradle Battery Door Vicks Braun Thermoscan

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-04-28
KMA Irrigator, Powered Nasal Ear, Nose, Throat Class 1 874.5550 2018-09-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-06-30
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-04-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-09-26
FRF Cleaner, Air, Medical Recirculating General Hospital Class 2 880.5045 2007-11-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-06-13
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 1992-06-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-03-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2011-01-04
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2008-09-18
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2021-12-22
FRF Cleaner, Air, Medical Recirculating General Hospital Class 2 880.5045 2007-11-19
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-05-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-11-18
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2007-11-19
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-12-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-08-15
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-07-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2018-07-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-07-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2014-05-22
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-01-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2008-06-17
KFZ Humidifier, Non-Direct Patient Interface (Home-Use) Anesthesiology Class 1 868.5460 2006-03-28
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-05-26
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

Aditi Agashe Business: Kaz USA, Inc., A Helen of Troy Company Email: aagashe@helenoftroy.com Phone: (508) 4907224

Related Public Records

Same Entity

Kaz USA, Inc., A Helen of Troy Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010405299 Kaz USA, Inc., A Helen of Troy Company Olive Branch, MS, US
3006169981 Kaz USA, Inc., A Helen of Troy Company MARLBOROUGH, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004871905. Last updated year: 2026. Please use registration number 3004871905 when referencing this establishment in official correspondence.
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