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Medical Guide

์˜๋ฃŒ์šฉ๊ฐ€์ด๋“œ

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number Reception No. 22-1020. Approved on Jun 13, 2022. Registered by Asrex 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
Class I
Basic Information
Item Serial Number
2022003013
License Number
Reception No. 22-1020
์ˆ˜์‹ 22-1020ํ˜ธ
Classification Number
A64050.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Medical Guide
์˜๋ฃŒ์šฉ๊ฐ€์ด๋“œ
Official English Name
Guide for medical use
Company Information
Entity Name (Company)
Asrex Korea
์•„์Šค๋ ‰์Šค์ฝ”๋ฆฌ์•„(์œ )
Entity Address
์„œ์šธํŠน๋ณ„์‹œ ๊ฐ•๋‚จ๊ตฌ ํ…Œํ—ค๋ž€๋กœ 521 20์ธต(์‚ผ์„ฑ๋™)
Manufacturer
Arthrex California Incorporated,Arthrex Manufacturing, Inc.
Category
Import business
์ˆ˜์ž…์—…
Business License Number
์ œ 4030 ํ˜ธ
Important Dates & Status
Item Approval Date
Jun 13, 2022
Business Permit Date
Feb 13, 2017
Expiration Period
2022-06-13 ~ 2027-06-12
For Export
์•„๋‹ˆ์˜ค
Model Information
Model Name
AR-2255CG-02
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