This company has registrations in United States, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 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 | K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | 2023-10-05 |
| US | K152091 | Fingertip Pulse Oximeter | 2016-08-18 |
| US | K152089 | Wrist Pulse Oximeter | 2016-08-17 |
| BR | 80423859003 | Sistema de Exame de Saúde Multiparâmetro HES-7 | Class II |
| BR | 80423850003 | Analisador de Urina Semiautomático HCU02 | Class II |
| BR | 81628880042 | Kit LabPoc Renal - Kit Perfil Renal Point of Care | Class II |