South Korea MFDS registration In vitro water22-4145
Real-time gene amplification device
KO: 실시간유전자증폭장치
South Korea·Class II·Mast Bio Co., Ltd.·Approved Mar 21, 2022Basic information
- Item Serial Number
- 2022001427
- License Number
- In vitro water22-4145
- Classification Number
- N01030.01(2)
- Device Class (Risk Classification)
- Class II
- Classification Name
- Real-time gene amplification device
- Official English Name
- Real-time gene amplificator, nucleic acid
체외수인22-4145호
실시간유전자증폭장치
Company information
- Entity Address
- 경기도 성남시 수정구 청계산로 734 5층(고등동, 마스트빌딩)
- Manufacturer
- DIATRON MI Plc
- Category
- Import business
- Business License Number
- 체외 제 1194 호
수입업
Important dates & status
- Item Approval Date
- Mar 21, 2022
- Business Permit Date
- Feb 07, 2006
- Expiration Period
- 2022-03-21 ~ 2027-03-20
- For Export
- 아니오
Model information
- Model Name
- MOL1011
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 water22-4145. Approved on Mar 21, 2022. 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 II