South Korea MFDS registration Reception No. 22-1443

Medical Guide

KO: 의료용가이드
South Korea flagSouth Korea·Class I·Asrex Korea·Approved Aug 23, 2022
Basic information
Item Serial Number
2022004294
License Number
Reception No. 22-1443
수신22-1443호
Classification Number
A64050.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Medical Guide
의료용가이드
Official English Name
Guide for medical use
Company information
Entity Name (Company)
Asrex Korea
아스렉스코리아(유)
Entity Address
서울특별시 강남구 테헤란로 521 20층(삼성동)
Manufacturer
Triangle Manufacturing Company, Inc.
Category
Import business
수입업
Business License Number
제 4030 호
Important dates & status
Item Approval Date
Aug 23, 2022
Business Permit Date
Feb 13, 2017
Expiration Period
2022-08-23 ~ 2027-08-22
For Export
아니오
Model information
Model Name
AR-1610H
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number Reception No. 22-1443. Approved on Aug 23, 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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