This company has registrations in United States, Canada — 2 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 | K090804 | NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD | 2009-11-05 |
| US | K062019 | RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD | 2006-08-17 |
| US | K050171 | IT NASAL MASK | 2005-05-04 |
| CA | 63813 | INNOMED-AIRE PLUS CPAP SYSTEM | Class II |
| CA | 63889 | INNOMED-AIRE CPAP SYSTEM | Class II |
| CA | 69268 | REMREST HEATED HUMIDIFIER | Class II |