This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia — 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 | K161295 | MiniBox + | 2016-10-21 |
| US | K141793 | PULMONE MINIBOXPFT 2.0 | 2015-03-06 |
| US | K133051 | PULMONE MINIBOX PFT TM | 2014-05-02 |
| BR | 81464759037 | MiniBox+ | Class II |