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Sign in to claim this brandSEJOY BIOMEDICAL CO., LTD.
China·CN-MF-000008447
Last updated September 17, 2026
Information
- Country
- China
- Address
- Area C, Building 2, No.365, Wuzhou Road, Hangzhou City, China
- Website
- www.sejoy.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Wu Jianhua
- EUDAMED SRN
- CN-MF-000008447
- FDA FEI Number
- 3005395953
- DUNS Number
- —
Catalogue (59)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| One Step Oxycodone Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| SARS-CoV-2 Antigen Rapid Test Cassette | COVG-602ST | EUDAMED | IVD devices for self-testing | Active |
| SEJOY Blood Glucose Test Strips | BS-102 | EUDAMED | IVD Annex II List B | Active |
| Dengue NS1 Antigen Rapid Test | Cassette | EUDAMED | IVD General | Active |
| Hemoglobin Test Strip | HS-101 | EUDAMED | IVD devices for self-testing | Active |
| Multi-function Monitoring System | CDS-101 | EUDAMED | IVD General | Active |
| Typhoid IgG/IgM Rapid Test | Cassette | EUDAMED | IVD General | Active |
| LH One Step Ovulation Test | LH-101/LH-102/LH-103 | EUDAMED | IVD devices for self-testing | Active |
| Multi-drug Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Lipid Panel Monitoring System | BF-101 | EUDAMED | IVD General | Active |
| Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System | K240640 | FDA 510(k) | Class II | Active |
| One Step Tricyclic Antidepressants Rapid Test | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Marijuana Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Phencyclidine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| H.pylori Antibody Rapid Test | Cassette | EUDAMED | IVD General | Active |
| One Step Propoxyphene Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Benzodiazepines Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Malaria Plasmodium Falciparum Rapid Test (whole blood) | Cassette | EUDAMED | IVD General | Active |
| One Step Cocaine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Morphine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| PGB One Step Pregabalin Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Tramadol Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Urinalysis Reagent Strips | URS-110 | EUDAMED | IVD General | Active |
| Dengue IgG/IgM Rapid Test Device | Cassette | EUDAMED | IVD General | Active |
| Hemoglobin Monitoring control solution | HC-101 | EUDAMED | IVD devices for self-testing | Active |
| MCT One Step Methcathinone Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Blood Glucose Monitoring system | BG-707 | EUDAMED | IVD Annex II List B | Active |
| The K2 One Step Synthetic Cannabis Test (colloidal gold method) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Barbiturates Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Malaria P.f ＆Pan Rapid Test (whole blood) | Cassette | EUDAMED | IVD General | Active |
| Influenza A+B Rapid Test | Cassette | EUDAMED | IVD General | Active |
| The ETG One Step Ethyl- β-D-Glucuronide Test (colloidal gold method) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Adenovirus Rapid Test (Feces) | Cassette | EUDAMED | IVD General | Active |
| Digital Fertility Testing System | Digital Fertility Tracker and LH One Step Ovulation Test | EUDAMED | IVD devices for self-testing | Active |
| One Step Methylenedioxymethamphetamine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Ketamine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Methadone Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Amphetamine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Fentanyl Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| One Step Opiate Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Strep A Rapid Test | ISTA-8112 | EUDAMED | IVD General | Active |
| Sejoy | BS-606 | EUDAMED | IVD Annex II List B | Active |
| One Step Ethylenediamine-dimethylphosphinic Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Hemoglobin Monitoring meter | HB-101,HB-201,HB-202 | EUDAMED | IVD devices for self-testing | Active |
| The 6-MAM One Step 6-Monoacetylmorphine Test (colloidal gold method) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| Uric Acid Monitoring Test Strips | US-101 | EUDAMED | IVD devices for self-testing | Active |
| One Step Methamphetamine Rapid Test (Urine) | Strip,Cassette,Panel,Cup | EUDAMED | IVD General | Active |
| SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test | COIF-522 | EUDAMED | IVD General | Active |
| Dengue IgG／IgM／NS1 Combo Rapid Test | Cassette | EUDAMED | IVD General | Active |
| hCG One Step Pregnancy Test | Strip,Cassette,Midstream | EUDAMED | IVD devices for self-testing | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sejoy Biomedical Co., Ltd. US