This company has registrations in United States, Canada, South Korea, Australia, Israel, Russia — 6 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 | K141441 | MENNTOR X7 | 2015-01-09 |
| US | K131789 | CEREBRALOGIK- AEEG | 2013-12-27 |
| US | K123792 | HORIZON XVU (FFR) | 2013-08-30 |
| CA | 3401 | ENVOY PATIENT MONITOR | Class III |
| CA | 3414 | HORIZON SE (CATHLAB) | Class III |
| CA | 3732 | ENSEMBLE CENTRAL STATION MONITOR | Class III |