This company holds 55 NMPA certificates in China and has registrations in European Union, Brazil, Hong Kong — 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 2026-09-02. 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20253402124 | 游离前列腺特异性抗原（fPSA）测定试剂盒 （免疫荧光层析法） | Class III |
| CN | 国械注准20253401895 | 总前列腺特异性抗原（tPSA）测定试剂盒（免疫荧光层析法） | Class III |
| CN | 国械注准20153400767 | 奈瑟氏淋球菌抗原检测试剂盒（免疫荧光法） | Class III |
| CN | 国械注准20153400495 | 阴道毛滴虫检测试剂盒（免疫荧光法） | Class III |
| EU | 06971348761202 | Free Thyroxine（FT4） Diagnostic Kit ( Immunochromatographic Assay) | IVD general |
| EU | 06971348764661 | C-Reactive Protein (CRP) Diagnostic Kit (Immunochromatographic Assay) | IVD C |
| EU | 06971348762650 | C-Reactive Protein (CRP) Diagnostic Kit (Immunochromatographic Assay) | IVD C |
| EU | 06971348764685 | D-dimer（DD) Diagnostic Kit (Immunochromatographic Assay) | IVD C |
| BR | 81797610039 | Fluorecare T4 | Class II |
| BR | 81797610040 | Fluorecare fT4 | Class II |
| BR | 81797610026 | Fluorecare Estradiol (E2) | Class II |