Company profile

Roche Diagnostics Korea

KO: 한국로슈진단(주)
South Korea flagSouth Korea·서울특별시 강남구 테헤란로108길 22 , 4층~8층(대치동, 서경빌딩)·1,201 devices·Registered Mar 15, 1999 – Sep 25, 2023
1,201
Total devices
5
Device classes
Mar 15, 1999
Earliest approval
Sep 25, 2023
Latest approval
Device class distribution

Breakdown of 1,201 devices by regulatory classification

Unknown
926
77.1% of total
Class III
117
9.7% of total
Class II
74
6.2% of total
Class I
70
5.8% of total
Class IV
14
1.2% of total
Registered devices (10 most recent shown)

Click on any device for detailed registration information

About this profile

Complete regulatory portfolio for Roche Diagnostics Korea in South Korea's medical device market. This company has 1,201 medical devices registered with South Korea MFDS, with registrations dating from Mar 15, 1999 to Sep 25, 2023.

Browse the complete device portfolio including device classifications, license numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive South Korea MFDS registration data, helping global MedTech companies analyze market presence and regulatory compliance for medical device manufacturers in South Korea.

Free DatabasePowered by Pure Global AIMFDS Official Data1,201 Devices