This company has registrations in United States, Israel, Russia — 3 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 | K032516 | HIOX80 AEROSOL ADAPTER | 2004-03-04 |
| US | K031745 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | 2004-02-13 |
| US | K031883 | LYRA NASAL MASK | 2003-08-25 |