Bischof-Sproll-Str. 2, Tuttlingen, Germany, 78532
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| ALLOGRAFT RING SURGICAL KIT | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Bone Pin | 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) |
| Bone Screw | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Burs and Drills, dental | 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) |
| DIAMOND DISC | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| DIAMOND TULIP | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| PILOT DRILL | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| PLANATOR | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| TREPHINE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| USTOMED Bone Fixation/Bone Augmentation Systems - PIN | 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) |
| Ustomed Container System | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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