FDA Registration
Active
🇨🇳 China
Wrist Digital Blood Pressure Monitor Moderl BSX323
Reg #: 3015542362
·
FEI: 3015542362
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SHENZHEN BSX TECHNOLOGY ELECTRONICS CO.,LTD
- Registration Number
- 3015542362
- FEI Number
- 3015542362
- Status
- Active
- Expiry Year
- 2025
- 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
- K241578
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 | 2025-03-22 |
Proprietary Names
Wrist Digital Blood Pressure Monitor Moderl BSX323
Wrist Digital Blood Pressure Monitor Moderl BSX315
Wrist Digital Blood Pressure Monitor Moderl BSX313
Wrist Digital Blood Pressure Monitor Moderl BSX322
Wrist Digital Blood Pressure Monitor Moderl BSX353
Wrist Digital Blood Pressure Monitor Moderl BSX312
Wrist Digital Blood Pressure Monitor Moderl BSX355
Wrist Digital Blood Pressure Monitor Moderl BSX325
Wrist Digital Blood Pressure Monitor Moderl BSX352
Establishment Types
Manufacture Medical Device