This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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 | K240087 | RT Carbon ECG Leads | 2024-09-13 |
| US | K202138 | Cardiac Trigger Monitor | 2021-05-14 |
| US | K203653 | MRI PPG Patient Cable | 2021-03-02 |
| CA | 15723 | OHMEDA ENGUARD 2000 PULSE OXIMETER | Class III |