Manufacturer and brand owner in Hangzhou, Zhejiang, China. 5 device types, 11 products catalogued, 1 clearance.
Sejoy Biomedical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Kit, Test, Pregnancy, Hcg, Over The Counter, System, Test, Blood Glucose, Over The Counter and 3 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
FDA registration record for Sejoy Biomedical Co., Ltd. | Registered name | SEJOY BIOMEDICAL CO., LTD. |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005395953 |
| FEI number | 3005395953 |
| DUNS | 545241999 |
| Establishment type | Manufacturer |
Location
Address of Sejoy Biomedical Co., Ltd. | City | Hangzhou |
| Province | Zhejiang |
| Address | Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic Development Zone |
| Postal code | 311100 |
| Country | China |
Clearances
1 clearance names Sejoy Biomedical Co., Ltd. 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 Sejoy Biomedical Co., Ltd. | Founded | 2002 |
| Main products | Blood glucose monitoring systems, Hemoglobin monitoring systems, Lipid panel systems, Infectious disease tests, Women’s healthcare tests |
| Certifications | ISO 13485, CE, FDA, RoHS, REACH, MDSAP |
| Export markets | Global |
| OEM and ODM | Offered |
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.