Data / Medical devices / China / Beijing Kingst Medical Device Co., Ltd.
Beijing Kingst Medical Device Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Beijing Kingst Medical Device Co., Ltd. is registered with the FDA (registration 3012733231) in Beijing, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012733231
- Address
- 5/F, Building 3, No.27, Yongwang Road Z-park Daxing Bio-medicine Industry Park, Dist. Daxing, Beijing, China, 102600
- Owner or operator
- Beijing Kingst Medical Device Co., Ltd. (10053621)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 30, 2018
- Registered through
- 2026
- Brand names listed
- CO2 Mainstream Module, CO2 Mainstream Sensor, CO2 Sidestream Module, CO2 Sidestream Sensor, Capno-H, Capno-M, Capno-M+, Capno-S, Capno-S+,CapnoCore2, Capnograph and Oximeter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2020 | K192488 | CO2 Sidestream Module | CCK | Substantially Equivalent | Beijing Kingst Commercial & Trade Co., Ltd. | accessdata.fda.gov |
| May 21, 2020 | K192446 | CO2 Mainstream Module | CCK | Substantially Equivalent | Beijing Kingst Commercial & Trade Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 22, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.