Sino Medical Sciences Technology Inc.
Manufacturer and brand owner in Tianjin, China. 1 device type, 2 products catalogued, 2 clearances.
Sino Medical Sciences Technology Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Catheters, Transluminal Coronary Angioplasty, Percutaneous. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
1device type
2products catalogued under its own name
2510(k) clearances
Registration
| Registered name | SINO MEDICAL SCIENCES TECHNOLOGY INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009205152 |
| FEI number | 3009205152 |
| DUNS | 528191055 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 赛诺医疗科学技术股份有限公司 |
|---|---|
| Unified social credit code | 91120116666113159A |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | TEDA Biopharm Res. Building B and 4th Floor Building A, #5 4th St. TEDA, |
| Postal code | 300457 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class 2 | SC Honkytonk, NC Rockstar | 2023 | 12 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| SC Honkytonk | LOX | 48 |
| NC Rockstar | LOX | 44 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223022 | 2023-02-15 | LOX | Traditional | This company |
| K222538 | 2022-12-21 | LOX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Factory area | 30,000 sq m (10,000 sq m clean room) |
| Main products | Coronary stent systems, Intracranial drug-eluting stents, Mitral valve replacement, HT SUPREME, ACCUFIT |
| Certifications | Shanghai SST Listed 2019 |
| Export markets | Asia, Europe, Latin America, Africa, USA, Japan |
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.
The manufacturer named here can complete this record.