This company has registrations in United States, Brazil, Israel — 3 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 | K250425 | Ultraviolet Phototherapy Device | 2025-04-07 |
| US | K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | 2018-06-08 |
| US | K170536 | ECG Disposable Lead Wire | 2017-04-24 |
| BR | 81634710003 | Eletrodos para ECG | Class I |
| BR | 81634710004 | Cabo para transdutor de pressão invasiva | Class I |
| BR | 81634710005 | Tubo extensor de PNI | Class I |