| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| MoMe Software Platform | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
Get alerts on new registrations, recalls, and regulatory changes.