Unispatech Co L T D

FDA Filings

This page includes the latest FDA filings for Unispatech 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: 3011298181
• FEI Number: 3011298181
• Name: JAMES LEE
• Owner & Operator: Unispatech Co., Ltd.
• Contact Address: 42-10 Taejanggongdan-Gil ; Wonju-si KR-42 Gangweondo 220962 KR
• Official Correspondent:
  • Jungdong Lee
  • 82-033-7489064-x
• US Agent:
  • JAMES LEE
  • YTS GLOBAL INC
  • 703 3408178
  • 703 3722838
  • FDA@YTSGLOBAL.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7406 ALBAN STATION COURT SUITE A108; Springfield, VA 22150 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IRT JAMES LEE [Unispatech Co., Ltd.]	Theranova	2015-12-11
ISA JAMES LEE [Unispatech Co., Ltd.]	Theranova	2015-01-12

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019090754775	Pusan,South Korea -> Los Angeles, California	ELECTRIC SPRAY KARIS SET8543 70 2020	2 PKG
2018060222844	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	THERANOVA	2 PKG