Anumana Limited, Manchester Road, Manchester Road, Wilmslow, Cheshire East, SK9 1BQ
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | 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) |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | 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) |
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | 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) |
| Low Ejection Fraction AI-ECG Algorithm | 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) |
| NeuTrace EP Mapping System v.2.1 | 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) |
| WatchMate Software | 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) |
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