This company has registrations in United States, Canada — 2 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 | K232536 | Soldier Microcatheter | 2024-02-23 |
| US | K180904 | Sniper Infusion Catheter with Balloon Occlusion | 2018-06-08 |
| US | K142692 | Occlusion Balloon Catheter | 2015-05-31 |