Unit 1D Annacotty Business Park, Co. Limerick, Ireland, none
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Transurethral Catherization Safety System | 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) |
| Transurethral Catheter Safety Valve (Class Medical TUC Safety Valve) | 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) |
| Transurethral Catheter Safety Valve (TUCSV) (80050) | 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) |
| TUCSV | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
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