Remedi Co L T D

FDA Filings

This page includes the latest FDA filings for Remedi Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013779985
• FEI Number: 3013779985
• Name: REMEDI CO., LTD.
• Owner & Operator: Remedi Co., Ltd.
• Contact Address: #1409, IS BIZ Tower, 26 Yangpyeong-ro 21 ; Seoul KR-NOTA 072NN KR
• Official Correspondent:
  • Chang Seongho
  • 82-2-6968-2041
• US Agent:
  • Lee Strong
  • 510KFDA, Inc.
  • 386 6720450
  • lee@510kfda.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2F, 69-14, Sakju-ro 145beon-gil ; Chuncheon Gangweondo, 24232 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08800060100243 REMEDI CO.,LTD.	ENDURO DR	2024-09-30
GUDID 08800060100236 REMEDI CO.,LTD.	ENDORO DR ES70 X-ray Source	2024-07-31
GUDID 08800060100151 REMEDI CO.,LTD.	REMEX KA6	2022-04-21
PMN K212144 Remedi Co. Ltd.	Remex KA6	2021-08-03
PMN K200284 Remedi Co. Ltd.	R-Sensor, R-Sensor	2020-02-28
PMN K180561 | EHD REMEDI CO., LTD.	T-100	2019-05-09