This company holds 64 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, South Korea — 5 overseas markets. EU UDI-DI records ≥300, 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 2026-09-02. 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 | 苏械注准20262400574 | 心肌肌钙蛋白I/肌酸激酶同工酶/肌红蛋白测定试剂盒（荧光免疫层析法） | Class II |
| CN | 苏械注准20262400439 | 生长激素测定试剂盒（荧光免疫层析法） | Class II |
| CN | 苏械注准20262400269 | 心脏型脂肪酸结合蛋白测定试剂盒（荧光免疫层析法） | Class II |
| CN | 苏械注准20262400124 | B型利钠肽测定试剂盒（荧光免疫层析法） | Class II |
| EU | D-CNMF000014455-COV-S728Y | — | IVD general |
| EU | D-CNMF000014455-COV-S718W | — | IVD general |
| EU | D-CNMF000014455-COV-S618T | — | IVD general |
| EU | D-CNMF000014455-COV-S318J | — | IVD general |
| UK | 62645 | Blood Glucose Meter | IVD Devices for Self-Testing |
| UK | 62646 | Blood Glucose Meter | IVD Devices for Self-Testing |
| UK | 41819 | Blood Glucose Control Solution | IVD general |
| BR | 81464750130 | Analisador de hemoglobina glicada A1cChek Pro | Class II |
| BR | 81464750131 | Analisador de Hemoglobina Glicada A1c EZ 2.0 | Class II |
| BR | 81464750132 | Família A1cChek Pro Kit | Class II |