This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 | K213915 | BIB Stent Placement Catheter | 2022-01-12 |
| US | K211910 | Z-6 Atrioseptostomy Catheter | 2021-07-19 |
| US | K211134 | BIB Stent Placement Catheter | 2021-05-27 |
| BR | 80102511257 | Cateteres MULLINS - X PTA | Class II |