This company holds 192 NMPA certificates in China and has registrations in European Union, Brazil, Canada — 3 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 2026-09-03. 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20263401731 | 人副流感病毒核酸检测试剂盒（荧光PCR法） | Class III |
| CN | 国械注准20263401474 | 乙型肝炎病毒核酸测定试剂盒（荧光PCR法） | Class III |
| CN | 国械注准20263401453 | 人类CYP2C9和VKORC1基因分型检测试剂盒（荧光PCR法） | Class III |
| CN | 国械注准20263401391 | 肺炎衣原体/肺炎支原体核酸检测试剂盒（荧光PCR法） | Class III |
| EU | 06928103082102 | — | IVD A |
| EU | 06928103083000 | — | IVD A |
| EU | 06928103006627 | — | IVD A |
| EU | 06928103006610 | — | IVD A |
| BR | 82213470002 | SMART 32 | Class I |
| BR | 80102513051 | Kit de extração ou purificação de RNA/DNA | Class I |
| BR | 80102513052 | Instrumento para extração de ácidos nucleicos Smart32 Plus | Class I |