Saykia Corp

FDA Filings

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

FDA Registration(s)

• Registration Number: 3013530359
• FEI Number: 3013530359
• Name: SAYKIA CORPORATION
• Owner & Operator: SAYKIA Corporation
• Contact Address: No.32-19, Pucai Rd., Puyan Township ; Changhua County TW-CHA Changhua 51649 TW
• US Agent:
  • Shu-Chen Cheng
  • ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
  • 614 5888168
  • ceirs.jen@msa.hinet.net
• Importing Logistics Registration:
  • Importer: HSI, LLC
  • Address: 555 N. EI Camino Real, Suite A-252 ; San Clemente, CA 92672 UNITED STATES
  • Phone: 1 949 2764538
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.32-19, Pucai Rd., Puyan Township ; Changhua County Changhua, 51649 TW
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K090738 | CAH SAYKIA CORPORATION	Breathing Circuit Bacterial Filter	2020-02-03
PMN K032878 | CAH SAYKIA CORPORATION	SAYKIA	2016-12-22
KGZ SAYKIA CORPORATION	SAYKIA	2016-12-22
KFZ SAYKIA CORPORATION	SAYKIA	2016-12-22
CAI SAYKIA CORPORATION	SAYKIA	2016-12-22
BYD SAYKIA CORPORATION	SAYKIA	2016-12-22

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202006106676	Kaohsiung,China (Taiwan) -> Savannah, Georgia	HME FILTER HARMONIZED TARIFF NUMBER HTS 9019 2000 . .	120 CTN
2020042112870	Kaohsiung,China (Taiwan) -> Savannah, Georgia	HME FILTER HARMONIZED TARIFF NUMBER HTS 9019 2000 . .	120 CTN