This company holds 331 NMPA certificates in China and has registrations in European Union, United States, Brazil, Canada, Australia, Hong Kong, Israel — 7 overseas markets. EU UDI-DI records ≥293, the first 300 verified individually.
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20263401092 | 梅毒螺旋体抗体检测试剂盒（化学发光法） | Class III |
| CN | 国械注准20263400134 | 异常凝血酶原测定试剂盒（化学发光法） | Class III |
| CN | 国械注准20253402223 | 人绒毛膜促性腺激素及β亚单位测定试剂盒（化学发光法） | Class III |
| CN | 国械注准20253401061 | 乙型肝炎病毒核心抗体测定试剂盒（化学发光法） | Class III |
| EU | 06925912715320 | Fully Automatic Chemistry Analyzer | IVD A |
| EU | 06925912715450 | Fully Automatic Chemistry Analyzer | IVD A |
| EU | 06925912738831 | ANA Control | IVD B |
| EU | 06925912738824 | dsDNA IgG Control | IVD B |
| US | K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) | 2023-12-11 |
| BR | 80867150072 | iFlash-Testosterone | Class II |
| BR | 80867150073 | iFlash-Prolactin | Class II |
| BR | 80867150074 | iFlash-Progesterone | Class II |