Data / Medical devices / China / Sejoy Biomedical Co., Ltd.
Sejoy Biomedical Co., Ltd.: FDA-registered device maker in Hangzhou City Zhejiang, China, 2 510(k) clearances
Sejoy Biomedical Co., Ltd. is registered with the FDA (registration 3005395953) in Hangzhou City Zhejiang, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 8, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005395953
- Address
- Area C, Building 2, No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City Zhejiang, China, 311100
- Owner or operator
- SEJOY BIOMEDICAL CO., LTD. (9078355)
- Roles
- Manufacturer
- First device listed
- March 26, 2021
- Registered through
- 2027
- Brand names listed
- FSH One Step Menopause Test Midstream,FSH One Step Menopause Test Strip,FSH One Step Menopause Cassette, LH One Step Ovulation Test Midstream,LH One Step Ovulation Test Strip,LH One Step Ovulation Test Cassette, Sejoy hCG One Step Pregnancy Test Cassette, Sejoy hCG One Step Pregnancy Test Midstream, Sejoy hCG One Step Pregnancy Test Strip, Vivoo At-Home Fertility Test, Vivoo At-Home Ovulation & Pregnancy Tests, Vivoo At-Home Ovulation Test and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 8, 2024 | K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | NBW | Substantially Equivalent | Sejoy Biomedical Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K212447 | SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream | LCX | Substantially Equivalent | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
Updated October 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.