Block 5, Parkmore East Business Park, Parkmore, Co. Galway, Galway, Ireland, H91 V0TX
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| BioMimics 3D Peripheral Self-Expanding Stent 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) |
| BioMimics 3D Vascular Stent System | 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) |
| SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS | 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) |
| SWIRLGRAFT VASCULAR ACCESS GRAFT | 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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