1/F, 2/F, 3/F, Building 2, Wisdom Industrial Park, 1300 Jiangqiao Road, Bengshan District, Bengbu, China, 233000
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Digital Flexible Ureteroscope for Single Use | 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) |
| Renal Pressure Monitoring Processor | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Single Use Digital Flexible Ureteroscope (7.5F) | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Single Use Digital Flexible Ureteroscope w/ Pressure Monitoring | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Single Use Suction-Evacuation Ureteral Access Sheath | 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) |
| Videoscope Imaging Processor | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
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