Shenzhen BSX Technology Electronics Co., Ltd.
Manufacturer and brand owner in Shen Zhen, Guangdong, China. 5 device types, 7 products catalogued, 5 clearances.
Shenzhen BSX Technology Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Continuous Measurement Thermometer and 3 other device types. 7 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
5device types registered with the FDA
7products catalogued under its own name
5510(k) clearances
Registration
| Registered name | SHENZHEN BSX TECHNOLOGY ELECTRONICS CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015542362 |
| FEI number | 3015542362 |
| DUNS | 551105453 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市保身欣科技电子有限公司 |
|---|---|
| Unified social credit code | 914403000725235725 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shen Zhen |
|---|---|
| Province | Guangdong |
| Address | Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen |
| Postal code | 518116 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Continuous Measurement Thermometer | Class 2 | Infrared Thermometer BSX916, Infrared Thermometer BSX976 | 2021 | 115 |
| Light Based Over-The-Counter Hair Removal | Class 2 | IPL Hair Removal Device Model BSXT106, IPL Hair Removal Device Model HYU0-G602, IPL Hair Removal Device Model BSXT101, IPL Hair Removal Device Model BSXT102, IPL Hair Removal Device Model BSXT103, IPL Hair Removal Device Model YT301 | 2023 | 69 |
| Oximeter | Class 2 | Fingertip Pulse Oximeter Model BSX251 | 2020 | 70 |
| Oximeter, Infrared, Sporting, Aviation | Class 2 | Fingertip Pulse Oximeter Model BSX253, Fingertip Pulse Oximeter Model BSX233, Fingertip Pulse Oximeter Model BSX231 | 2021 | 29 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Arm-Type Electronic Blood Pressure Monitor Moderl BSX5228, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5826, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5021, Arm-Type Electronic Blood Pressure Monitor Moderl BSX580, Arm-Type Electronic Blood Pressure Monitor Moderl BSX558, Arm-Type Electronic Blood Pressure Monitor Moderl BSX583 and 31 more | 2019 | 98 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241578 | 2025-02-19 | DXN | Traditional | This company |
| K230097 | 2023-04-06 | OHT | Traditional | This company |
| K202296 | 2021-07-23 | FLL | Traditional | This company |
| K202324 | 2020-12-14 | DQA | Traditional | This company |
| K183058 | 2019-07-03 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 600 |
| Factory area | 20,000 m² |
| Main products | Blood pressure monitors, Pulse oximeters, Thermometers, Oxygen concentrators |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Shen FU Arts LAB | 15 |
| Shenzhen Joose Beauty Electronic Co., Ltd. | 13 |
| AOK Tooling Limited | 6 |
| SKG Health Technologies Co., Ltd. | 5 |
| Fran Wheel Enterprise Co., Ltd. | 4 |
| Shenzhenshi Hengmeite Technology Co., Ltd. | 4 |
| Shenzhen Kingyield Technology Co., Ltd. | 3 |
| Shenzhen Increcare Biotech Co., Ltd. | 1 |
| Tsuen LEE Metals & Plastic Toys Factory | 1 |
| Shenzhen Xiaobaimaijia Networktechnology Co., Ltd. | 1 |
| Chuan YI QI Tech Shen Zhen Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.