This company has registrations in United States — 1 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 | K241177 | React 71 Catheter | 2024-05-28 |
| US | K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | 2023-11-07 |
| US | K210230 | Phenom Catheters | 2021-02-25 |