South Korea MFDS registration Reception No. 21-1459

In vitro medical electrodes

KO: 체외형의료용전극
South Korea flagSouth Korea·Class I·GwangwooMedix Co., Ltd.·Approved Aug 02, 2021
Basic information
Item Serial Number
2021004297
License Number
Reception No. 21-1459
수신21-1459호
Classification Number
A58060.01(1)
Device Class (Risk Classification)
Class I
Classification Name
In vitro medical electrodes
체외형의료용전극
Official English Name
Electrode, external
Company information
Entity Name (Company)
GwangwooMedix Co., Ltd.
(주)광우메딕스
Entity Address
서울특별시 강남구 테헤란로 625 3층, 지하2층(삼성동, 덕명빌딩)
Manufacturer
Etymotic Research Inc.
Category
Import business
수입업
Business License Number
제 422 호
Important dates & status
Item Approval Date
Aug 02, 2021
Business Permit Date
Apr 13, 2005
Expiration Period
2021-08-02 ~ 2026-08-01
For Export
아니오
Model information
Model Name
ER3-26A and 1 other case
ER3-26A외 1건
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. 21-1459. Approved on Aug 02, 2021. Registered by GwangwooMedix Co., Ltd..

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 DatabasePowered by Pure Global AIMFDS Official DataClass I