South Korea MFDS registration In Vitro Reception No. 21-392
Medical immunofluorescence measurement device
KO: 의료용면역형광측정장치
South Korea·Class I·Mast Bio Co., Ltd.·Approved Mar 11, 2021Basic information
- Item Serial Number
- 2021001238
- License Number
- In Vitro Reception No. 21-392
- Classification Number
- K01020.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Medical immunofluorescence measurement device
- Official English Name
- Fluorimetric immunoassay analyzer(FIA), stationary
체외수신21-392호
의료용면역형광측정장치
Company information
- Entity Address
- 경기도 성남시 수정구 청계산로 734 5층(고등동, 마스트빌딩)
- Manufacturer
- VISIA imaging S.r.l.
- Category
- Import business
- Business License Number
- 체외 제 1194 호
수입업
Important dates & status
- Item Approval Date
- Mar 11, 2021
- Business Permit Date
- Feb 07, 2006
- Expiration Period
- 2021-03-11 ~ 2026-03-10
- For Export
- 아니오
Model information
- Model Name
- ZEUS dIFine
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. 21-392. Approved on Mar 11, 2021. Registered by Mast Bio 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