Room 1201, 12th Floor, Building 3, No. 580, Liye Road, Changhe Subdistrict, Binjiang District, Hangzhou, China (Zhejiang) Pilot Free Trade Zone, China, 310056
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 4K ICG Image Processing System | 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) |
| 4K NIR/ICG Imaging System | 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) |
| Camera Control Unit | 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) |
| Camera Head | 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) |
| Endoscopic Camera System | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Endoscopic Cold Light Source | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Endoscopic LED Cold Light Source | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| Fiber Optic Light Cable | 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) |
| Fuente De Luz Fría LED Para Endoscopia | 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) |
| Fuente De Luz Fría Para Endoscopia | 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) |
| Istruzioni per l'Uso Sistema di elaborazione delle immagini 4K NIR/ICG Sistema con telecamera endosco | 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) |
| Istruzioni per l'Uso Sistema di imaging 4K Sistema con telecamera endoscopica | 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) |
| Istruzioni per l'Uso Sorgente di luce fredda LED per uso endoscopico | 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) |
| Istruzioni per l'Uso Sorgente di luce fredda per uso endoscopico | 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) |
| Sistema De Cámara Endoscópico | 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) |
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