Manufacturer and brand owner in Changzhou, Jiangsu, China. 5 device types, 10 products catalogued, 1 clearance.
Sinolinks Medical Innovation, Inc. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Stapler, Skin, Staple, Implantable and 3 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2015.
Registration
FDA registration record for Sinolinks Medical Innovation, Inc. | Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008383115 |
| FEI number | 3008383115 |
| DUNS | 528192598 |
| Establishment type | Complaint-file establishment, Manufacturer |
Chinese Registration
Chinese company register details for Sinolinks Medical Innovation, Inc. | Chinese legal name | 江苏三联星海医疗器械有限公司 |
| Unified social credit code | 91320400766535615G |
| Source | NMPA UDI database |
Location
Address of Sinolinks Medical Innovation, Inc. | City | Changzhou |
| Province | Jiangsu |
| Address | NO.10 Ziwei Road, Zhonglou Zone |
| Postal code | 213032 |
| Country | China |
Clearances
1 clearance names Sinolinks Medical Innovation, Inc. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Sinolinks Medical Innovation, Inc. | Founded | 2004 |
| Main products | Surgical mechanical suturing instruments, Surgical repair materials, Surgical ligation systems, Endoscopic anastomotic devices, Hernia repair patches |
| Certifications | ISO13485, CE0197, National High-Tech Enterprise (2014), FDA 510K |
| Export markets | 1000+ domestic and foreign hospitals |
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.