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 | K030035 | IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE | 2003-06-25 |
| US | K013938 | IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE | 2002-01-28 |
| US | K011586 | IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE | 2001-11-16 |