Manufacturer and brand owner in Changsha, Hunan, China. 4 device types, 13 products catalogued.
Sansure Biotech Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Sample Concentrator, Real Time Nucleic Acid Amplification System and 2 other device types. 13 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
FDA registration record for Sansure Biotech Inc. | Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016619649 |
| FEI number | 3016619649 |
| DUNS | 421167832 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Sansure Biotech Inc. | Chinese legal name | 圣湘生物科技股份有限公司 |
| Unified social credit code | 91430100673566826X |
| Source | NMPA UDI database |
Location
Address of Sansure Biotech Inc. | City | Changsha |
| Province | Hunan |
| Address | No. 680, Lusong Road, Yuelu District |
| Postal code | 410205 |
| Country | China |
From the Company
Published by the company on its own website, not by the FDA.
Information published by Sansure Biotech Inc. | Main products | Nucleic acid detection reagents, Automated nucleic acid extraction systems, Real-time PCR analyzers, Gene testing services, NGS sequencing systems |
| Certifications | CE IVDR, CFDA, NMPA |
| Export markets | Europe and global markets |
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.