FDA Registration
Active
🇨🇳 China
BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2
Reg #: 3004871905
·
FEI: 3004871905
·
Expires 2025
Products
1
Proprietary Names
19
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
- K181242
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 protected]
- Phone
- 508 4907236
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2018-07-30 |
Proprietary Names
BRAUN Sensian 4 3-in-1 Thermometer BNT100USV2
Braun BNT400 No Touch + Forehead Thermometer
BNT400BUS
Braun No touch 3-in-1 Thermometer BNT400LA
Braun No touch 3-in-1 Thermometer BNT400BUSV2
BNT400BSP
Braun No touch 3-in-1 Thermometer BNT400CA
Braun No touch 3-in-1 Thermometer BNT400BWE
Braun No touch 3-in-1 Thermometer BNT400AP
BNT300 Braun No Touch + Forehead Thermometer
BNT300US Braun No Touch + Forehead Thermometer
Braun No touch 3-in-1 Thermometer BNT400JP
Braun No touch 3-in-1 Thermometer BNT400AR
Braun No touch 3-in-1 Thermometer BNT400EE
Braun No touch 3-in-1 Thermometer BNT400BUS
Braun No touch 3-in-1 Thermometer BNT400WE
Braun No touch 3-in-1 Thermometer BNT400AU
Braun No touch 3-in-1 Thermometer BNT400KO
Braun No Touch + Forehead Thermometer BNT300USV1
Establishment Types
Export Device to the United States But Perform No Other Operation on Device