This company has registrations in United States, Brazil, Taiwan, Singapore, Australia, Hong Kong, Israel — 7 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 | K230528 | Extension Set | 2023-12-01 |
| US | K213004 | Needle Free Connector | 2022-05-10 |
| US | K202578 | KardiFlex NC Coronary Dilatation Catheter | 2021-05-06 |
| BR | 81504799174 | Reservatório Cassete Fotoprotetor | Class II |
| BR | 81504799195 | Reservatório Cassete de Medicamento | Class II |
| BR | 81504799196 | Reservatório Cassete de Medicamento | Class II |