South Korea MFDS registration In Vitro Reception No. 20-1818
Medical immunosecurity measurement device
KO: 의료용면역비탁측정장치
South Korea·Class I·Mast Bio Co., Ltd.·Approved Jul 30, 2020Basic information
- Item Serial Number
- 2020004822
- License Number
- In Vitro Reception No. 20-1818
- Classification Number
- K01040.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Medical immunosecurity measurement device
- Official English Name
- Immunonephelometry analyzer
체외수신20-1818호
의료용면역비탁측정장치
Company information
- Entity Address
- 경기도 성남시 수정구 청계산로 734 5층(고등동, 마스트빌딩)
- Manufacturer
- GA Generic Assays GmbH
- Category
- Import business
- Business License Number
- 체외 제 1194 호
수입업
Important dates & status
- Item Approval Date
- Jul 30, 2020
- Business Permit Date
- Feb 07, 2006
- Expiration Period
- 2020-10-08 ~ 2030-11-30
- For Export
- 아니오
Model information
- Model Name
- DotDiver2.0
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. 20-1818. Approved on Jul 30, 2020. Registered by Mast Bio Co., Ltd..
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