This company holds 21 NMPA certificates in China.
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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| CN | 国械注准20253401580 | 人类EGFR/ALK基因突变检测试剂盒（可逆末端终止测序法） | Class III |
| CN | 国械注准20253400372 | 人类HER2基因扩增检测试剂盒（荧光原位杂交法） | Class III |
| CN | 国械注准20233400009 | 人类EGFR基因突变检测试剂盒（荧光PCR法） | Class III |
| CN | 浙械注准20262210195 | 非小细胞肺癌（EGFR/ALK）基因突变分析软件 | Class II |