X-ray device for digital mammography
๋์งํธ์ ๋ฐฉ์ดฌ์์ฉ์์ค์ ์ฅ์น
This Class II medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number Suin No. 22-4449. Approved on Sep 15, 2022. Registered by Synex Inc..
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MFDS Official Data
Class II
Basic Information
Item Serial Number
2022004715
License Number
Suin No. 22-4449
์์ธ22-4449ํธ
Classification Number
A11060.02(2)
Device Class (Risk Classification)
Class II
Classification Name
X-ray device for digital mammography
๋์งํธ์ ๋ฐฉ์ดฌ์์ฉ์์ค์ ์ฅ์น
Official English Name
Mammographic x-ray system, stationary, digital
Company Information
Entity Address
์์ธํน๋ณ์ ๊ฐ๋จ๊ตฌ ๋
ผํ๋ก 430 10์ธต(์ญ์ผ๋, ์์ธ์ํ์)
Manufacturer
Hologic,Inc.
Category
Import business
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Business License Number
์ 43 ํธ
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
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Model Information
Model Name
3Dimensions System
