FDA Registration
Active
🇨🇳 China
SHENZHEN BSX TECHNOLOGY ELECTRONICS CO.,LTD
Reg #: 3015542362
·
FEI: 3015542362
·
Expires 2026
Products
5
Proprietary Names
46
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SHENZHEN BSX TECHNOLOGY ELECTRONICS CO.,LTD
- Registration Number
- 3015542362
- FEI Number
- 3015542362
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen
- City
- Shen Zhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K183058
Owner / Operator
- Firm Name
- Shenzhen BSX Technology Electronics Co.,Ltd
- Operator Number
- 10060909
- Address
- Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen
- City
- Shen Zhen
- State
- Guangdong
- Postal Code
- 518116
- Country
- CN
- Correspondent
- Kai Fang
US Agent
- Business Name
- CTI US lnc.
- Contact Name
- Robin Zhang
- Address
- 1455 Lincoln Pkwy E Ste 230
- City
- Atlanta
- State
- GA
- ZIP
- 30346
- Country
- US
- [email protected]
- Phone
- 313 2885666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-07-11 |
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2023-04-17 |
| Oximeter, Infrared, Sporting, Aviation | OCH | Class 2 | Cardiovascular | No | 2021-02-03 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2021-08-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-12-19 |
Proprietary Names
Arm-Type Electronic Blood Pressure Monitor Moderl BSX5035
Arm-Type Electronic Blood Pressure Monitor Moderl BSX515
Arm-Type Electronic Blood Pressure Monitor Moderl BSX580
Arm-Type Electronic Blood Pressure Monitor Moderl BSX556
Arm-Type Electronic Blood Pressure Monitor Moderl BSX532
Arm-Type Electronic Blood Pressure Monitor Moderl BSX553
Arm-Type Electronic Blood Pressure Monitor Moderl BSX558
Arm-Type Electronic Blood Pressure Monitor Moderl BSX573
Arm-Type Electronic Blood Pressure Monitor Moderl BSX593
Arm-Type Electronic Blood Pressure Monitor Moderl BSX568
Arm-Type Electronic Blood Pressure Monitor Moderl BSX595
Arm-Type Electronic Blood Pressure Monitor Moderl BSX595 SMART
Arm-Type Electronic Blood Pressure Monitor Moderl BSX505
Arm-Type Electronic Blood Pressure Monitor Moderl BSX525
Arm-Type Electronic Blood Pressure Monitor Moderl BSX527
Arm-Type Electronic Blood Pressure Monitor Moderl BSX593 SMART
Arm-Type Electronic Blood Pressure Monitor Moderl BSX523
Arm-Type Electronic Blood Pressure Monitor Moderl BSX583
Arm-Type Electronic Blood Pressure Monitor Moderl BSX579
Arm-Type Electronic Blood Pressure Monitor Moderl BSX516
Arm-Type Electronic Blood Pressure Monitor Moderl BSX513
Arm-Type Electronic Blood Pressure Monitor Moderl BSX561
Arm-Type Electronic Blood Pressure Monitor Moderl BSX5113
Arm-Type Electronic Blood Pressure Monitor Moderl BSX5125
Arm-Type Electronic Blood Pressure Monitor Moderl BSX5826
IPL Hair Removal Device Model HYU0-G602
IPL Hair Removal Device Model BSXT106
IPL Hair Removal Device Model BSXT101
IPL Hair Removal Device Model BSXT103
IPL Hair Removal Device Model BSXT102
IPL Hair Removal Device Model YT301
Fingertip Pulse Oximeter Model BSX231
Fingertip Pulse Oximeter Model BSX233
Fingertip Pulse Oximeter Model BSX253
Infrared Thermometer BSX916
Infrared Thermometer BSX976
Fingertip Pulse Oximeter Model BSX251
Wrist Digital Blood Pressure Monitor Moderl BSX315
Wrist Digital Blood Pressure Monitor Moderl BSX355
Wrist Digital Blood Pressure Monitor Moderl BSX325
Wrist Digital Blood Pressure Monitor Moderl BSX313
Wrist Digital Blood Pressure Monitor Moderl BSX353
Wrist Digital Blood Pressure Monitor Moderl BSX323
Wrist Digital Blood Pressure Monitor Moderl BSX312
Wrist Digital Blood Pressure Monitor Moderl BSX322
Wrist Digital Blood Pressure Monitor Moderl BSX352
Establishment Types
Manufacture Medical Device