Beijing Bywave Sensing Medical Technology Co., Ltd.
Registered establishment in Beijing, China. 2 device types, 1 clearance.
Beijing Bywave Sensing Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Wire, Guide, Catheter, Transducer, Pressure, Catheter Tip. Its earliest product listing with the FDA dates from 2021.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018784828 |
| FEI number | 3018784828 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京佰为深医疗科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Room 301, 1st to 3rd Floor, Building 33, Yard 6, Hengye 7th Street, Tongzhou District Beijing, P. R. China |
| Postal code | 100086 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Transducer, Pressure, Catheter Tip | Class 2 | LiPPS™ Intravascular Pressure Sensing System | 2021 | 4 |
| Wire, Guide, Catheter | Class 2 | LiPPS™ Intravascular Pressure Sensing System | 2021 | 10 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201720 | 2021-02-18 | DQX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Employees | 100 |
| Main products | MEMS Fabry-Perot cavity fiber sensors, Fiber Bragg Grating sensors, optical fiber demodulation technologies |
| Export markets | medical, petroleum, electric power, transportation |
Nearby Manufacturers
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.
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