This company has registrations in United States, Brazil, Taiwan, South Korea, Australia, Israel, Russia — 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 | K221472 | Filter and HME/Filter | 2023-02-08 |
| BR | 80081499021 | Sistema Fechado de Aspiração Traqueal HFA | Class II |
| BR | 80081499023 | Sistema Fechado de Aspiração Traqueal HFA | Class II |
| BR | 80633669013 | Circuitos Respiratórios Aquecidos Descartáveis | Class II |