Medicustek Inc

FDA Filings

This page includes the latest FDA filings for Medicustek 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: 3010594861
• FEI Number: 3010594861
• Name: MEDICUSTEK INC.
• Owner & Operator: MedicusTek Inc.
• Contact Address: 9F-1, No. 3, Yuanqu St. Nangang Dist.; Taipei TW-TPQ Taipei - District 115 TW
• Official Correspondent:
  • Chih-Ning Huang
  • 886-2-26558672-216
• US Agent:
  • Mark Hostak
  • 704 2811724
  • mark.hostak@medicustekusa.com
• Importing Logistics Registration:
  • Importer: MedicusTek USA Corporation
  • Address: 1839 Santiago DR. Newport Beach ; Newport Beach, CA 92660 UNITED STATES
  • Email Address: Jonathan.tong@medicustek.com
  • Phone: 1 626 9050839
  • FAX: 1 626 9050839
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9F-1, No. 3, Yuanqu St. Nangang Dist.; Taipei Taipei - District, 115 TW
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
FMW MEDICUSTEK INC.	SensableCare Pad Fitted Sheet	2018-11-11
PJO MEDICUSTEK INC.	SensableCare Box; SensableCare System Software	2017-07-19
KMI MEDICUSTEK INC.	SensableCare Mattress; SensableCare Pad	2013-11-05

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201903138830	Kaohsiung,China (Taiwan) -> Long Beach, California	BOX PAD SHIP TO: MEDICUSTEK USA CORPORATION 2215 ALTON PKWY IRVINE, CA 92606, USA ATTN: A RIEL CHEN TEL NO: 949-335-7187 / 832-863-0242 EMAIL: ARIEL.CHEN@MEDICUSTEKUSA.COM (H.S.COD E:8531.80 9404.29) 69 CTNS ON 9 PLTS	69 CTN
2019021558742	Kaohsiung,China (Taiwan) -> Long Beach, California	BOX PAD SHIP TO: MEDICUSTEK USA CORPORATION 2215 ALTON PKWY IRVINE, CA 92606, USA ATTN: A RIEL CHEN TEL NO: 949-335-7187 / 832-863-0242 EMAIL: ARIEL.CHEN@MEDICUSTEKUSA.COM (H.S.COD E:8531.80 9404.29) 69 CTNS ON 9 PLTS	69 CTN
2019010358589	Kaohsiung,China (Taiwan) -> Los Angeles, California	PAD, SENSABLE CARE PAD	48 CTN
2018111051225	Kaohsiung,China (Taiwan) -> Los Angeles, California	0100200 PAD LST NO. D204619 SENSABLE CARE PA . .	55 PKG
2018080251082	Kaohsiung,China (Taiwan) -> Los Angeles, California	PAD LST NO.: D204619 HS CODE:9404.29	1 CTN