This company has registrations in United States, Brazil, Saudi Arabia, 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 | K182327 | Patient Cables and Leadwires , Disposable ECG Leadwires | 2019-01-30 |
| US | K173194 | Temperature Probe | 2018-10-10 |
| US | K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | 2018-09-07 |
| BR | 80393910043 | Cabos Paciente ECG Descartável - Orantech | Class I |
| BR | 80393919007 | SENSORES DE TEMPERATURA TURBO - ORANTECH | Class II |
| BR | 81760450007 | CABO TRANSDUTOR DE PRESSÃO ORANTECH | Class I |
| SA | ME0000017149SFDAA00001 | Noninvasive Blood Pressure Cuff | — |
| SA | ME0000018229SFDAA00021 | SpO2 Adapter Cable | — |