This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 9 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 | K201468 | Pulse Oximeter | 2021-01-25 |
| US | K192343 | Patient Monitor | 2019-12-31 |
| US | K172792 | Handheld Pulse Oximeter, Model SP-20 | 2018-11-13 |
| BR | 80901119018 | Oxímetro de Pulso Portátil e Mesa | Class II |
| BR | 80102519128 | Oxímetro de Pulso Portátil | Class II |
| BR | 81611329011 | Oxímetro Portátil Gaslive - GS Pulse Pro | Class II |
| SA | ME0000005033SFDAA00008 | Reusable Electrode | — |
| CA | 86372 | FINGERTIP OXIMETER | Class III |