South Korea MFDS registration Reception No. 21-1874

Class 1 Medical Image Transmission Device Software

KO: 1등급의료영상전송장치소프트웨어
South Korea flagSouth Korea·Class I·Oriental Medical Equipment Co., Ltd.·Approved Oct 14, 2021
Basic information
Item Serial Number
2021005557
License Number
Reception No. 21-1874
수신21-1874호
Classification Number
E11010.02(1)
Device Class (Risk Classification)
Class I
Classification Name
Class 1 Medical Image Transmission Device Software
1등급의료영상전송장치소프트웨어
Official English Name
Medical image, picture archiving and communication system, software class 1
Company information
Entity Name (Company)
Oriental Medical Equipment Co., Ltd.
동방의료기(주)
Entity Address
서울특별시 강남구 선릉로100길 30 3층일부 (삼성동,유니콘빌딩)
Manufacturer
Welch Allyn, Inc.
Category
Import business
수입업
Business License Number
제 8 호
Important dates & status
Item Approval Date
Oct 14, 2021
Business Permit Date
Jul 27, 2004
Expiration Period
2021-10-14 ~ 2026-10-13
For Export
아니오
Model information
Model Name
iExaminer Pro
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. 21-1874. Approved on Oct 14, 2021. Registered by Oriental Medical Equipment 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