This company has registrations in United States, Brazil, Taiwan, Singapore, Israel, Russia — 6 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 | K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | 2018-05-23 |
| US | K171521 | DUS R-50S (Urine Chemistry system) | 2018-02-16 |
| US | K102188 | CYBOW READER, MODELS 300 & 720 | 2011-08-09 |
| BR | 10387650124 | DIFLUSS 11M | Class II |
| BR | 80638720108 | BIOCON R-50S | Class II |
| BR | 80405180005 | ANALISADOR DE URINA COMBOSTIK R-300 | Class II |