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Personal Continuous Blood Glucose Measurement System

๊ฐœ์ธ์šฉ์ฒด๋‚ด์—ฐ์†ํ˜ˆ๋‹น์ธก์ •์‹œ์Šคํ…œ

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Suhe 23-397. Approved on Dec 20, 2023. Registered by Abbott Korea.

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.

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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023007184
License Number
Suhe 23-397
์ˆ˜ํ—ˆ23-397ํ˜ธ
Classification Number
A26110.02
Device Class (Risk Classification)
Unknown
Classification Name
Personal Continuous Blood Glucose Monitoring System
๊ฐœ์ธ์šฉ ์ฒด๋‚ด ์—ฐ์†ํ˜ˆ๋‹น ์ธก์ • ์‹œ์Šคํ…œ
Official English Name
Continuous glucose monitoring systems, self-testing, in vivo
Company Information
Entity Name (Company)
Abbott Korea
ํ•œ๊ตญ์• ๋ณดํŠธ(์œ )
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 371 ํ˜ธ
Important Dates & Status
Item Approval Date
Dec 20, 2023
Business Permit Date
Mar 30, 2005
Expiration Period
2023-12-20 ~ 2028-12-19
Model Information
Model Name
FreeStyle Libre 2
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