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South Korea MFDS registration In Vitro No. 22-663

Heart disease marker test reagent

KO: 심질환표지자검사시약
South Korea flagSouth Korea·Class III·Ohsang Healthcare Co., Ltd.·Approved Oct 04, 2022
Basic information
Item Serial Number
2022005015
License Number
In Vitro No. 22-663
체외제허22-663호
Classification Number
K02030.01(3)
Device Class (Risk Classification)
Class III
Classification Name
Heart disease marker test reagent
심질환표지자검사시약
Official English Name
IVD reagents for cardiac marker
Company information
Entity Name (Company)
Ohsang Healthcare Co., Ltd.
(주)오상헬스케어
Entity Address
경기도 안양시 동안구 안양천동로 132 (호계동)
Category
Manufacturing
제조업
Business License Number
체외 제 652 호
Important dates & status
Item Approval Date
Oct 04, 2022
Business Permit Date
Nov 24, 1997
For Export
예
Model information
Model Name
IIM-0001TR
About this record

This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro No. 22-663. Approved on Oct 04, 2022. 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 DataClass III