South Korea MFDS registration Suin No. 22-4449
X-ray device for digital mammography
KO: 디지털유방촬영용엑스선장치
South Korea·Class II·Synex Inc.·Approved Sep 15, 2022Basic information
- Item Serial Number
- 2022004715
- License Number
- Suin No. 22-4449
- Classification Number
- A11060.02(2)
- Device Class (Risk Classification)
- Class II
- Classification Name
- X-ray device for digital mammography
- Official English Name
- Mammographic x-ray system, stationary, digital
수인22-4449호
디지털유방촬영용엑스선장치
Company information
- Entity Address
- 서울특별시 강남구 논현로 430 10층(역삼동, 아세아타워)
- Manufacturer
- Hologic,Inc.
- Category
- Import business
- Business License Number
- 제 43 호
수입업
Important dates & status
- Item Approval Date
- Sep 15, 2022
- Business Permit Date
- Aug 30, 2004
- Expiration Period
- 2022-09-15 ~ 2027-09-14
- For Export
- 아니오
Model information
- Model Name
- 3Dimensions System
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 Suin No. 22-4449. Approved on Sep 15, 2022. Registered by Synex Inc..
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