No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha, HuNan, China, 410000
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 98×10 UT-ML-A1 | 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) |
| 98×20 UT-C-C1 | 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) |
| BLOOMDEN DENTAL ZIRCONIA BLANK | 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) |
| Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| BLOOMDEN DENTAL ZIRCONIA PRE-SHADED BLANK | 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) |
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