This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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 | K162023 | CardioDay V2.5 | 2017-03-24 |
| US | K130516 | CARDIODAY | 2013-08-23 |
| US | K130785 | SEER 1000 | 2013-07-26 |
| BR | 81464759059 | HeartX Recorder | Class II |
| BR | 80071260392 | Software de análise de ECG Holter | Class II |
| SA | ME0000009146SFDAA00001 | ECG Cable for CM 3000-12 BT | — |
| SA | ME0000009146SFDAA00002 | ECG Cable for SEER 1000 | — |