This company has registrations in United States, Brazil, South Korea, Australia, Israel — 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 | K211747 | Reusable NIBP Cuff | 2021-09-23 |
| US | K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | 2020-06-22 |
| US | K173368 | Reusable & Disposable SpO2 Sensors | 2018-08-31 |
| BR | 82096699001 | SENSOR DE TEMPERATURA ENBEX | Class II |
| BR | 82096690001 | MANGUEIRA DE AR DE PRESSÃO NÃO INVASIVA (PNI) ENBEX | Class I |
| BR | 82096690002 | CABO DE PRESSÃO INVASIVA (PI) ENBEX | Class I |