770 Legacy Place, Floor 2, Suite 34, Dedham, Boston, United States, 02026
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Etiometry Platform | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Etiometry Platform (DAV 5.4 RAE 9.2) | 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) |
| ETIOMETRY PLATFORM SOFTWARE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| T3 Platform software | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| T3 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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