This company has registrations in United States, Canada, Taiwan — 3 overseas markets. The China NMPA lookup is still pending.
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 |
|---|---|---|---|
| US | K200317 | Support Catheter | 2020-05-14 |
| US | K183679 | Occlusion Balloon Catheter | 2019-04-24 |
| US | K160561 | Boosting Catheter | 2016-11-02 |