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| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Aura myopia prevention and control spectacle lenses:Aura | 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) |
| Aura myopia prevention and control spectacle lenses:Aura Pro | 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) |
| GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | 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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