Leadtek Research Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3010071455
• FEI Number: 3010071455
• Name: LEADTEK RESEARCH INC.
• Owner & Operator: Leadtek Research Inc.
• Contact Address: 18F,No.166, Jian-Yi Rd., Chung Ho Dist. ; New Taipei City TW-NOTA 23511 TW
• Official Correspondent:
  • Terry Kuan
  • 886-2-82265800-169
• US Agent:
  • Paul Dryden
  • ProMedic, LLC
  • 239 3076061
  • 239 3076070
  • paul.dryden@promedic.cc
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2F, 5F, No.2, Alley 11, Lane 327, Sec. 2, Chung San Rd., Chung H ; New Taipei City, 23585 TW
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K210032 Leadtek Research Inc.	Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)	2021-09-01
GUDID 00190263830145 LEADTEK RESEARCH, INC.	Alvital	2020-07-21
GUDID 00190263830138 LEADTEK RESEARCH, INC.	Alvital	2020-07-21
GUDID 00190263830121 LEADTEK RESEARCH, INC.	Leadtek	2020-07-21
GUDID 00190263830114 LEADTEK RESEARCH, INC.	Leadtek	2020-07-21
PMN K193350 Leadtek Research Inc.	Leadtek Fingertip Pulse Oximeter	2020-04-27

Related Finance Registrations

NCAGE Code	1NLY8	LEADTEK RESEARCH INC
NCAGE Code	SJ591	LEADTEK RESEARCH INC.
CAGE Code	1NLY8	LEADTEK RESEARCH INC
CAGE Code	SJ591	LEADTEK RESEARCH INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020062923756	Shilong,China (Taiwan) -> Los Angeles, California	PCOIP GRAPHICS ZERO CLIENT DEVICE	54 CTN
202006276039	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	COMPUTER PARTS	60 CTN
202006267377	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	COMPUTER PARTS	60 CTN
2020061946127	Shilong,China (Taiwan) -> Los Angeles, California	PCOIP GRAPHICS ZERO CLIENT DEVICE	54 CTN
2020061852317	Shilong,China (Taiwan) -> Los Angeles, California	PCOIP GRAPHICS ZERO CLIENT DEVICE	54 CTN
202005235947	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	COMPUTER PARTS	60 CTN
202005225678	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	COMPUTER PARTS	60 CTN
202001013741	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	COMPUTER PARTS	40 CTN