This company has registrations in United States — 1 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 | K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | 2025-07-29 |
| US | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | 2023-10-06 |
| US | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | 2016-03-11 |