This company holds 28 NMPA certificates in China and has registrations in United States, United Kingdom, Brazil, Canada, Australia, Israel, Russia — 7 overseas markets.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
Business registration data from Tianyancha, as of 2026-09-01. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注准20183401691 | 恶性疟原虫抗原检测试剂盒 (胶体金法) | Class III |
| CN | 国械注准20183401686 | 恶性疟原虫/间日疟原虫抗原检测试剂盒 (胶体金法) | Class III |
| CN | 国械注准20173401238 | 戊型肝炎病毒IgM抗体检测试剂盒（胶体金法） | Class III |
| CN | 国械注准20173401233 | 甲型肝炎病毒IgM抗体检测试剂盒（胶体金法） | Class III |
| UK | 65841 | Follicle Stimulating Hormone(FSH) Test | IVD Devices for Self-Testing |
| UK | 43774 | Pregnancy Test | IVD Devices for Self-Testing |
| UK | 54255 | Ovulation Test | IVD Devices for Self-Testing |
| US | K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | 2024-01-26 |
| US | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | 2015-11-02 |
| US | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | 2015-07-16 |
| BR | 81464750107 | Teste de Gravidez | Class II |
| BR | 80258020062 | FAST TEST GRAVIDEZ SEMANAS | Class II |
| CA | 96636 | EASY1STEP DOA TEST | Class II |