This company has registrations in United States, Taiwan, South Korea, Australia, Israel — 5 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 | K241888 | Single-use Balloon Dilatation Catheter | 2024-12-20 |
| US | K172985 | Ligation Device | 2018-06-14 |