FDA Registration
Active
🇺🇸 United States
Kaz USA, Inc., A Helen of Troy Company
Reg #: 3006169981
·
FEI: 3006169981
·
Expires 2026
Products
11
Proprietary Names
127
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- Kaz USA, Inc., A Helen of Troy Company
- Registration Number
- 3006169981
- FEI Number
- 3006169981
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400 Donald Lynch Blvd Ste 300
- City
- MARLBOROUGH
- State
- MA
- ZIP
- 01752
- Country
- US
Regulatory Submissions
- 510(k) Number
- K970211
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 1992-06-24 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2021-12-22 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-07-23 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2021-01-06 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2008-09-18 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2018-09-06 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2011-08-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-06-25 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2007-11-19 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2026-06-01 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2026-06-16 |
Proprietary Names
Dunlap
Soft Heat
Bruder
BRAUN ExactFit 1 Upper arm blood pressure monitor
Braun Infrared Forehead Thermometer
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
Vicks
Braun Thermoscan
Smart Temp
Mind + Body Care
SoftHest
Braun Thermoscan PRO 4000 series
Braun Thermoscan IRT 4000 series
Thermometer
Vicks® SmartTemp Thermometer
Braun® Nasal Aspirator
Vicks Underarm Thermometer
SoftHeat
Braun ThermoScan 3 High Speed Compact Ear Thermometer
Braun Nasal Aspirator Filters
Braun manual nasal aspirator
BRAUN EXACTFIT 3 UPPER ARM BLOOD PRESSURE MONITOR
BRAUN
VICKS NON CONTACT INFRARED BODY 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
Braun TempleSwipe Thermometer
Vicks, Instant Digital Electric Thermometer
Vick ComfortFlex Thermometer
Vicks Digital Thermometer
Braun Digital Thermometer
Vicks Cordless Steam Inhaler
Kaz
Walgreens
Protec
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 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
Vicks RapidRead Digital Thermometer
VICKS NO TOUCH THERMOMETER
BRAUN NO TOUCH THERMOMETER
Braun Precision Sensor
Welch Allyn
Probe Covers
Braun ThermoScan® 7+ connect Ear Thermometer
Braun ThermoScan Infrared Ear Thermometer
Infrared Ear Thermometer
Braun ThermoScan Lens Filters
Vicks Pacifier
Braun Pulse Oximeter BPX801US
Braun ExactFit 1E Upper Arm Blood Pressure Monitor
Braun ExactFit 1E
Braun ExactFit 2
Thermometer with Charge Dock
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
Braun No Touch + Forehead Thermometer
Braun No touch 3-in-1 Thermometer
BRAUN Sensian 4 3-in-1 Thermometer
BRAUN ExactFit 2 connect Upper arm Blood pressure monitor
Braun ThermoScan Infrared Ear Thermometer IRT6525AP
Braun ThermoScan Infrared Ear Thermometer IRT6030AP
Braun ThermoScan Infrared Ear Thermometer IRT6525
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device