3rd Floor, Building 2 & Building 3, No.3,Gaoxin Jiu Road, Xiaoshan Economic and Technological Development Zone, Hangzhou, China, 311200
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Disposable Digital Flexible Ureteroscope | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| DISPOSABLE GRADUATED GUIDEWIRE | 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) |
| Disposable Graduated Guidewire for urological treatments | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| DISPOSABLE INTRARENAL-PRESSURE MONITORING URETERAL ACCESS SHEATH | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Disposable Nitinol Urological Retrieval Coil | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Disposable Stone Collector | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Disposable Stone Collector for Urological Treatments | Not 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) |
| Disposable Ureteral Access Sheath | Not 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) |
| Disposable Urological Guidewire | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| Disposable Urological Stone Extraction Basket | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Registered with EU (EUDAMED) |
| Disposable Waste Liquid Collection Bag | 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) |
| ELEPHANT IV | 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) |
| Equipment for Intrarenal Pressure Control During Ureteroscopy and Endoscopic Surgery and Related Accessories | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| INTELLIGENT PRESSURE-CONTROL SYSTEM | 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) |
| Medical Endoscope Image Processor | Not registered with US (FDA) | Registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE | 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) |
| SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE (TYPE A) | 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) |
| Ureteral Access Sheath | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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