South Korea MFDS registration In Vitro Reception No. 20-982
Clinical Examination Universal Quality Control Substance I.
KO: 임상검사범용정도관리물질Ⅰ
South Korea·Class I·Biorad Korea Co., Ltd.·Approved Apr 21, 2020Basic information
- Item Serial Number
- 2020002423
- License Number
- In Vitro Reception No. 20-982
- Classification Number
- J08060.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Clinical Examination Universal Quality Control Substance I.
- Official English Name
- General calibrators, controls or standards, classⅠ, for clinical chemistry
체외수신20-982호
임상검사범용정도관리물질Ⅰ
Company information
- Entity Address
- 서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
- Manufacturer
- Bio-Rad Laboratories Inc.
- Category
- Import business
- Business License Number
- 체외 제 719 호
수입업
Important dates & status
- Item Approval Date
- Apr 21, 2020
- Business Permit Date
- May 26, 2005
- Expiration Period
- 2020-10-08 ~ 2030-10-31
- For Export
- 아니오
Model information
- Model Name
- 00142A
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 In Vitro Reception No. 20-982. Approved on Apr 21, 2020. Registered by Biorad Korea 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 I