This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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 | K231406 | ClearumTM HS | 2023-06-14 |
| US | K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | 2020-10-08 |
| US | K160558 | RAPIDO HOLLOW-FIBRE DIALYZERS | 2016-11-18 |
| BR | 10349000860 | Linhas de Sangue para Hemodiálise | Class II |
| CA | 21338 | FORMULA DIALYSIS MACHINES | Class III |
| CA | 23674 | RAPIDO BLS (DIAPES MEMBRANE) HOLLOW FIBER HEMODIALYZER | Class III |
| CA | 65405 | HEMOX | Class II |