This company has registrations in United States, Brazil, Australia, Israel — 4 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 | K970739 | RMI HEMOCONCENTRATOR PREFERENCE PACK | 1997-07-08 |
| US | K964833 | RMI DUAL FLUID IRRIGATING SYRINGE | 1997-02-19 |
| US | K961927 | RMI HEMOCONCENTRACTOR TUBING SET | 1996-08-13 |
| BR | 10345339004 | KALOS | Class II |
| BR | 81187719001 | Dispositivo para eliminação de secreções das vias aéreas e assistente | Class II |