This company holds 350 NMPA certificates in China and has registrations in European Union, United States, Brazil, South Korea, Russia — 5 overseas markets. EU UDI-DI records ≥231, 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20263400634 | 葡萄糖-6-磷酸脱氢酶测定试剂盒（葡萄糖-6-磷酸底物法） | Class III |
| CN | 国械注准20263400353 | 乙型肝炎病毒表面抗体测定试剂盒（化学发光微粒子免疫检测法） | Class III |
| CN | 国械注准20263400337 | 乙型肝炎病毒表面抗原检测试剂盒（化学发光微粒子免疫检测法） | Class III |
| CN | 国械注准20263400157 | 乙型肝炎病毒核心抗体测定试剂盒（化学发光微粒子免疫检测法） | Class III |
| EU | 06936595776867 | Cleaning Solution(Direct Method) | IVD A |
| EU | 06936595780673 | Catecholamine Kit(LC-MS/MS) | IVD general |
| EU | 06936595780666 | Bile Acids Kit(LC-MS/MS) | IVD general |
| EU | 06936595773859 | Sample Diluent (CLIA) | IVD A |
| BR | 82832860080 | FAMÍLIA DE ANALISADORES BIOQUÍMICOS AUTOMÁTICOS QLX | Class II |
| BR | 80785070268 | Calibrador ISE VIDA RI | Class II |
| BR | 80785070270 | Família Controle ISE VIDA RI | Class II |