์ธ์ฆ ๋‚ด์—ญ

a FDA

๋ฏธ๊ตญ
FDA
Class1

SCOPEYE, METASCOPE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON

b Japan PMDA

์ผ๋ณธ
PMDA
Class1

METASCOPE, SCOPEYE

c Eu Spain

์œ ๋Ÿฝ
CMC
CE MDR Class1

SCOPEYE, METASCOPE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON

d Eu Swiss

์Šค์œ„์Šค
CMC
Swissmedic Class1

SCOPEYE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON

Frame 222

์˜๊ตญ
CMC
PARD Class1

SCOPEYE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON

f TGA austrailia

ํ˜ธ์ฃผ
TGA
Class1

SCOPEYE

g TFDA Taiwan

๋Œ€๋งŒ
TFDA
TFDA Class1

SCOPEYE

h DNV korea

๋Œ€ํ•œ๋ฏผ๊ตญ
DNV
ISO13485:2016

SCOPEYE

I KFDA Korea

๋Œ€ํ•œ๋ฏผ๊ตญ
ํ•œ๊ตญ์‹์•ฝ์ฒ˜
1๋“ฑ๊ธ‰ ์˜๋ฃŒ๊ธฐ๊ธฐ

SCOPEYE

j KFDA Korea

๋Œ€ํ•œ๋ฏผ๊ตญ
ํ•œ๊ตญ์‹์•ฝ์ฒ˜
1๋“ฑ๊ธ‰ ์˜๋ฃŒ๊ธฐ๊ธฐ

METASCOPE

k KFDA Korea

๋Œ€ํ•œ๋ฏผ๊ตญ
ํ•œ๊ตญ์‹์•ฝ์ฒ˜
1๋“ฑ๊ธ‰ ์˜๋ฃŒ๊ธฐ๊ธฐ

SCOPEYE 3D ADDON

l KFDA Korea

๋Œ€ํ•œ๋ฏผ๊ตญ
ํ•œ๊ตญ์‹์•ฝ์ฒ˜
1๋“ฑ๊ธ‰ ์˜๋ฃŒ๊ธฐ๊ธฐ

SCOPEYE 3D MICROVISION