Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, Wuxi, Jiangsu Province, China, 214135
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Confocal Microprobe Imaging System | 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) |
| Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); | 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) |
| Fiber Optic Microprobe | 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) |
| Shear Wave Quantificational Ultrasound Diagnostic System | Registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) | 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) |
| Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) | 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) |
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