South Korea MFDS registration In vitro waters No. 22-4529

Thyroid function hormone test reagent

KO: 갑상선기능호르몬검사시약
South Korea flagSouth Korea·Class II·Dong Aesti Co., Ltd.·Approved Nov 10, 2022
Basic information
Item Serial Number
2022005793
License Number
In vitro waters No. 22-4529
체외수인22-4529호
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)
Dong Aesti Co., Ltd.
동아에스티(주)
Entity Address
서울특별시 동대문구 천호대로 64 (용두동)
Manufacturer
DiaSorin Deutschland GmbH
Category
Import business
수입업
Business License Number
체외 제 561 호
Important dates & status
Item Approval Date
Nov 10, 2022
Business Permit Date
May 16, 2005
Expiration Period
2022-11-10 ~ 2027-11-09
For Export
아니오
Model information
Model Name
DiaSorin LIAISON TSH
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 waters No. 22-4529. Approved on Nov 10, 2022. Registered by Dong Aesti Co., Ltd..

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