Pure Global
South Korea MFDS registration In Vitro No. 23-1175

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Ohsang Healthcare Co., Ltd.·Approved Dec 26, 2023
Basic information
Item Serial Number
2023007277
License Number
In Vitro No. 23-1175
체외제허23-1175호
Classification Number
K05030.01
Device Class (Risk Classification)
Unknown
Classification Name
High-risk infection immunoassay reagent
고위험성감염체면역검사시약
Official English Name
IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than 'high risk pathogens', Infectious agents with moderate infectivity), immunological method
Company information
Entity Name (Company)
Ohsang Healthcare Co., Ltd.
(주)오상헬스케어
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 652 호
Important dates & status
Item Approval Date
Dec 26, 2023
Business Permit Date
Nov 24, 1997
Model information
Model Name
OI-01SO-DM
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro No. 23-1175. Approved on Dec 26, 2023. Registered by Ohsang Healthcare Co., Ltd..

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 devices in South Korea.

Free DatabasePowered by Pure Global AIMFDS Official DataUnknown