Cu Medical Systems Inc

FDA Filings

This page includes the latest FDA filings for Cu Medical Systems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

115480

DUNS 689987964

FDA Registration(s)

• Registration Number: 3007030999
• FEI Number: 3007030999
• Name: Elaine Duncan, MS. ME., RAC
• Owner & Operator: CU MEDICAL SYSTEMS, INC.
• Contact Address: 130-1, Donghwagongdan-ro, Munmak-eup; Wonju-si KR-42 Gangweondo 26365 KR
• Official Correspondent:
  • KWANG-YOUL LEE
  • 082-33-7477657-425
• US Agent:
  • Elaine Duncan, MS. ME., RAC
  • Paladin Medical, Inc.
  • 715 5496035
  • 715 5495380
  • duncan@paladinmedical.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 415 Valley View Trail ; Houlton, WI 54082 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 08809435480003 CU Medical Systems, Inc.	i-PAD	2020-03-09
PMN K062970 CU MEDICAL SYSTEMS, INC.	I-PAD	2008-01-22

Related Finance Registrations

NCAGE Code	9564F	CU MEDICAL SYSTEMS INC.
CAGE Code	9564F	CU MEDICAL SYSTEMS INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020041533729	Pusan,South Korea -> Oakland, California	SPECTACLE LENSES	1 PKG
2019071355695	Pusan,South Korea -> Oakland, California	SPECTACLE LENSES	1 PKG
2018123139616	Pusan,South Korea -> Oakland, California	PLASTIC SPECTACLE LENSE	3 PKG
2018011630756	Pusan,South Korea -> Oakland, California	PLASTIC SPECTACLE LENSE	1 PKG