This company has registrations in United States, Canada, 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 | K151835 | Vital Signs Patch System | 2016-02-05 |
| US | K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detector | 2016-01-15 |
| US | K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | 2015-09-11 |
| CA | 5088 | CARDIAC EVENT RECORDER | Class II |
| CA | 9236 | LIFESIGNS VITAL SIGNS MONITORING SYSTEM | Class II |
| CA | 32405 | CARD GUARD CG-2206 | Class II |