South Korea MFDS registration In vitro 23-4088

Thyroid function hormone test reagent

KO: 갑상선기능호르몬검사시약
South Korea flagSouth Korea·Class II·Roche Diagnostics Korea·Approved Feb 15, 2023
Basic information
Item Serial Number
2023000831
License Number
In vitro 23-4088
체외수인23-4088호
Classification Number
J11060.01(2)
Device Class (Risk Classification)
Class II
Classification Name
Thyroid function hormone test reagent
갑상선기능호르몬검사시약
Official English Name
IVD Reagents for thyroid function hormone tests
Company information
Entity Name (Company)
Roche Diagnostics Korea
한국로슈진단(주)
Entity Address
서울특별시 강남구 테헤란로108길 22 , 4층~8층(대치동, 서경빌딩)
Category
Import business
수입업
Business License Number
체외 제 730 호
Important dates & status
Item Approval Date
Feb 15, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-02-15 ~ 2028-02-14
For Export
아니오
Model information
Model Name
09043276190 1 case
09043276190외 1건
About this record

This Class II medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In vitro 23-4088. Approved on Feb 15, 2023. Registered by Roche Diagnostics Korea.

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