This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 | K231818 | METIC- Airway Balloon Catheter | 2023-11-15 |
| US | K190619 | Aspiron(TM) Aspiration Catheter | 2019-04-29 |
| US | K181023 | Mozec Rx PTCA Balloon Dilatation Catheter, Mozec NC Rx PTCA Balloon Dilatation Catheter | 2018-05-17 |
| BR | 10360810082 | Conjunto de Medidores para Bioprótese Pericárdica Dafodil - Mitral | Class I |
| BR | 10360810081 | Conjunto de Medidores para Bioprótese Pericárdica Dafodil - Aórtica | Class I |
| BR | 10360810059 | val de crimp - Ferramenta de Crimpagem para Válvula Transcateter Card | Class I |
| CA | 93032 | NEXGEN COBALT CHROMIUM CORONARY STENT SYSTEM | Class IV |