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Roche Diagnostics Korea

KO: 한국로슈진단(주)
South Korea서울특별시 강남구 테헤란로108길 22 , 4층~8층(대치동, 서경빌딩)1,201 devicesRegistered Mar 15, 1999 – Sep 25, 2023
VerifiedMFDS · Ministry of Food and Drug Safety registry
1,201
Total devices
5
Device classes
Mar 15, 1999
Earliest approval
Sep 25, 2023
Latest approval
Regulatory footprint
Search Roche Diagnostics Korea across other regulatory registries
ThailandEuropean UnionColombiaCanadaEcuadorSaudi Arabia
Device class distribution
Breakdown of 1,201 devices by regulatory classification
Unknown92677.1% of total
Class III1179.7% of total
Class II746.2% of total
Class I705.8% of total
Class IV141.2% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Cell and Tissue Staining Reagent II
세포및조직염색시약II
Sep 25, 2023
Class
Unknown
License Number
Extracorporeal water seal 23-4770
Cell and Tissue Staining Reagent II
세포및조직염색시약II
Sep 06, 2023
Class
Unknown
License Number
In Vitro Number 23-4752
Pathology Tissue Diagnosis Assistant Software II
병리조직진단보조소프트웨어II
Jun 23, 2023
Class
Unknown
License Number
In Vitro Water No. 23-244
Genetic testing reagent for high-risk infections
고위험성감염체유전자검사시약
Jun 01, 2023
Class
Unknown
License Number
In Vitro Hydrotherapy No. 23-222
Blood glucose test strip for clinical examination
임상검사용혈당검사지
May 12, 2023
Class
Unknown
License Number
In Vitro Recipient No. 23-4574
Pathology Tissue Diagnosis Assistant Software II
병리조직진단보조소프트웨어II
May 03, 2023
Class
Unknown
License Number
In Vitro Water No. 23-197
Pathology Tissue Diagnosis Assistant Software II
병리조직진단보조소프트웨어II
Apr 03, 2023
Class
Unknown
License Number
In Vitro Procedure No. 23-136
Other In Vitro Diagnostics Related Software II.
기타체외진단관련소프트웨어Ⅱ
Feb 16, 2023
Class
Unknown
License Number
In vitro water23-4092
Thyroid function hormone test reagent
갑상선기능호르몬검사시약
Feb 15, 2023
Class
Class II
License Number
In vitro 23-4088
High-risk infection immunoassay reagent
고위험성감염체면역검사시약
Feb 01, 2023
Class
Class III
License Number
In vitro water 23-25
View all 1,201 devices →
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.