Pure Global
South Korea MFDS registration Reception No. 23-156

Grade 1 Healthcare Gateway Software

KO: 1등급유헬스케어게이트웨이소프트웨어
South Korea flagSouth Korea·Class I·Synex Inc.·Approved Jan 30, 2023
Basic information
Item Serial Number
2023000498
License Number
Reception No. 23-156
수신23-156호
Classification Number
E05110.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Grade 1 Healthcare Gateway Software
1등급유헬스케어게이트웨이소프트웨어
Official English Name
U-healthcare gateway software class 1
Company information
Entity Name (Company)
Synex Inc.
(주)사이넥스
Entity Address
서울특별시 강남구 논현로 430 10층(역삼동, 아세아타워)
Category
Import business
수입업
Business License Number
제 43 호
Important dates & status
Item Approval Date
Jan 30, 2023
Business Permit Date
Aug 30, 2004
Expiration Period
2023-01-30 ~ 2028-01-29
For Export
아니오
Model information
Model Name
Dexcom Follow App
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number Reception No. 23-156. Approved on Jan 30, 2023. Registered by Synex Inc..

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 I