South Korea MFDS registration In vitro 23-4088
Thyroid function hormone test reagent
KO: 갑상선기능호르몬검사시약
Basic information
- Item Serial Number
- 2023000831
- License Number
- In vitro 23-4088
- Classification Number
- J11060.01(2)
- Device Class (Risk Classification)
- Class II
- Classification Name
- Thyroid function hormone test reagent
- Official English Name
- IVD Reagents for thyroid function hormone tests
체외수인23-4088호
갑상선기능호르몬검사시약
Company information
- Entity Address
- 서울특별시 강남구 테헤란로108길 22 , 4층~8층(대치동, 서경빌딩)
- Category
- Import business
- Business License Number
- 체외 제 730 호
수입업
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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