Data / Medical devices / China / Sino Medical Sciences Technology Inc.
Sino Medical Sciences Technology Inc.: FDA-registered device maker in Tianjin, China, 2 510(k) clearances
Sino Medical Sciences Technology Inc. is registered with the FDA (registration 3009205152) in Tianjin, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009205152
- Address
- TEDA Biopharm Res. Building B and 4th Floor Building A, #5 4th St. TEDA, Tianjin, China, 300457
- Owner or operator
- Sino Medical Sciences Technology Inc. (10062605)
- Roles
- Manufacturer
- First device listed
- January 15, 2023
- Registered through
- 2026
- Brand names listed
- NC ROCKSTAR, SC HONKYTONK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | 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 |
|---|---|---|---|---|---|---|
| February 15, 2023 | K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Sino Medical Sciences Technology, Inc. | accessdata.fda.gov |
| December 21, 2022 | K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Sino Medical Sciences Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 15, 2023. 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.