Pure Global

Holter electrocardiograph

ํ™€ํ„ฐ์‹ฌ์ „๊ณ„

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 Suin 23-4510. Approved on Apr 19, 2023. Registered by Synex Inc..

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 Database
Powered by Pure Global AI
MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023002335
License Number
Suin 23-4510
์ˆ˜์ธ23-4510ํ˜ธ
Classification Number
A26040.01
Device Class (Risk Classification)
Unknown
Classification Name
Holter electrocardiograph
ํ™€ํ„ฐ ์‹ฌ์ „๊ณ„
Official English Name
Electrocardiographic Holter analyser
Company Information
Entity Name (Company)
Synex Inc.
(์ฃผ)์‚ฌ์ด๋„ฅ์Šค
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 43 ํ˜ธ
Important Dates & Status
Item Approval Date
Apr 19, 2023
Business Permit Date
Aug 30, 2004
Expiration Period
2023-04-19 ~ 2028-04-18
Model Information
Model Name
AM-021
AC-021
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing