41-16, Cheoinseong-ro, Namsa-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do, South Korea, 17118
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| A1417MCW/A1717MCW/F1417MCW | 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) |
| ADD | 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) |
| ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | 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) |
| Digital flat panel X-ray detector | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Registered with EU (EUDAMED) |
| HAD1717MC | 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) |
| HnX-P1, HnX-PB | 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) |
| Portable X-ray 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) |
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