2495 Xenium Lane N, Minneapolis, MN, United States, 55441
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Optilume | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Optilume Basic Urological Balloon Dilation Catheter | 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) |
| Optilume™ BPH Catheter System | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| OPTILUME BPH PROSTATIC DILATION DCB CATHETER 105 FR | 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) |
| OPTILUME BPH PROSTATIC DILATION DCB CATHETER 90 FR | 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) |
| OPTILUME BPH PROSTATIC PRE-DILATION CATHETER | 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) |
| Optilume® High Pressure Urological Balloon Dilation Catheter | 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) |
| Optilume Urethral Drug Coated Balloon catheter | Registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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