Registered establishment in Jinshan District, Shanghai, China. 2 device types.
Shanghai Medconn Biotechnology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Hemoglobin A1c Test System, Assay, Glycosylated Hemoglobin. Its earliest product listing with the FDA dates from 2026.
Registration
FDA registration record for Shanghai Medconn Biotechnology Co., Ltd. | Registered name | SHANGHAI MEDCONN BIOTECHNOLOGY CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043654757 |
| FEI number | 3043654757 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Shanghai Medconn Biotechnology Co., Ltd. | Chinese legal name | 上海惠中生物科技有限公司 |
| Unified social credit code | 91310114133607244C |
| Source | NMPA UDI database |
Location
Address of Shanghai Medconn Biotechnology Co., Ltd. | City | Jinshan District |
| Province | Shanghai |
| Address | No. 1018 Weichang Road, Shanyang Town, |
| Postal code | 201508 |
| Country | China |
Clearances
No clearance names Shanghai Medconn Biotechnology Co., Ltd. as applicant. 2 are 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 Shanghai Medconn Biotechnology Co., Ltd. | Founded | 1992 |
| Main products | in vitro diagnostic products, hemoglobin A1C analyzer, diagnostic reagents |
| Export markets | Thailand, Vietnam |
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.