300 Wellington Road, Mulgrave, Australia, 3170
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Anterior Segment Lens | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| HP-OCT (HP-OCT) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| The HP-OCT Instrument | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| The HP-OCT™ Instrument and Accessories | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| The Unity DX Instrument | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| UNITY® DX | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| UNITY DX (UDX) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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