Approval
U.S.A
FDA
Class1
SCOPEYE, METASCOPE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON
Japan
PMDA
Class1
METASCOPE, SCOPEYE
EU
CMC
CE MDR Class1
SCOPEYE, METASCOPE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON
Swiss
CMC
Swissmedic Class1
SCOPEYE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON
UK
CMC
PARD Class1
SCOPEYE, SCOPEYE 3D MICROVISION, SCOPEYE 3D ADDON
Austrailia
TGA
Class1
SCOPEYE
Taiwan
TFDA
TFDA Class1
SCOPEYE
South Korea
DNV
ISO13485:2016
SCOPEYE
South Korea
한국식약처
1등급 의료기기
SCOPEYE
South Korea
한국식약처
1등급 의료기기
METASCOPE
South Korea
한국식약처
1등급 의료기기
SCOPEYE 3D ADDON
South Korea
한국식약처
1등급 의료기기
SCOPEYE 3D MICROVISION
