This company holds 58 NMPA certificates in China and has registrations in European Union, United States, Israel, Russia — 4 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20253402569 | 甲型流感病毒（Flu A）抗原检测试剂盒（免疫层析法） | Class III |
| CN | 国械注准20253402438 | 甲/乙型流感病毒（Flu A/B）抗原检测试剂盒（免疫层析法） | Class III |
| CN | 国械注准20173404232 | 梅毒螺旋体抗体检测试剂盒（胶体金法） | Class III |
| CN | 国械注准20173404142 | 胃幽门螺旋杆菌（HP）抗原检测试剂盒（胶体金法） | Class III |
| EU | 06977775224211 | HP Ag H.pylori Antigen Rapid Test | IVD B |
| EU | 06977775223825 | FOB Fecal Occult Blood Rapid Test | IVD B |
| EU | 06977775222316 | — | IVD B |
| EU | 06977775222194 | Chlamydia Trachomatis Rapid Test | IVD C |
| US | K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test | 2023-12-20 |
| US | K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests | 2016-04-18 |
| US | K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 | 2015-04-17 |