Grade 1 Healthcare Gateway Software
1๋ฑ๊ธ์ ํฌ์ค์ผ์ด๊ฒ์ดํธ์จ์ด์ํํธ์จ์ด
This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number Reception No. 23-156. Approved on Jan 30, 2023. Registered by Synex Inc..
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MFDS Official Data
Class I
Basic Information
Item Serial Number
2023000498
License Number
Reception No. 23-156
์์ 23-156ํธ
Classification Number
E05110.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Grade 1 Healthcare Gateway Software
1๋ฑ๊ธ์ ํฌ์ค์ผ์ด๊ฒ์ดํธ์จ์ด์ํํธ์จ์ด
Official English Name
U-healthcare gateway software class 1
Company Information
Entity Address
์์ธํน๋ณ์ ๊ฐ๋จ๊ตฌ ๋
ผํ๋ก 430 10์ธต(์ญ์ผ๋, ์์ธ์ํ์)
Category
Import business
์์
์
Business License Number
์ 43 ํธ
Important Dates & Status
Item Approval Date
Jan 30, 2023
Business Permit Date
Aug 30, 2004
Expiration Period
2023-01-30 ~ 2028-01-29
For Export
์๋์ค
Model Information
Model Name
Dexcom Follow App
