Alpinion Usa

FDA Filings

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

Alpinion Usa holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• ALPINION MEDICAL SYSTEMS Co., Ltd.

FDA Registration(s)

• Registration Number: 3009293490
• FEI Number: 3009293490
• Name: ALPINION USA
• Owner & Operator: Alpinion USA
• Contact Address: 21222 30th Dr. SE Ste C-122; Bothell WA 98021 US
• Official Correspondent:
  • Kevin Chun
  • 1-425-9491059-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 21222 30th Dr SE Ste C-122 ; Bothell, WA 98021 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K172732 | IYO ALPINION USA	E-Cube 8	2017-12-15
PMN K172732 | IYN ALPINION USA	E-Cube 8	2017-12-15
PMN K172732 | ITX ALPINION USA	E-Cube 8	2017-12-15
PMN K161439 | IYO ALPINION USA	E-Cube 11	2016-10-20
PMN K161439 | IYN ALPINION USA	E-Cube 11	2016-10-20
PMN K161439 | ITX ALPINION USA	E-Cube 11	2016-10-20
PMN K153424 | IYO ALPINION USA	E-Cube i7	2016-04-11
PMN K153424 | IYN ALPINION USA	E-Cube i7	2016-04-11
PMN K153424 | ITX ALPINION USA	E-Cube i7	2016-04-11
PMN K150773 | IYO ALPINION USA	E-Cube 15	2016-04-11
PMN K150773 | IYN ALPINION USA	E-Cube 15	2016-04-11
PMN K150773 | ITX ALPINION USA	E-Cube 15	2016-04-11
PMN K142884 | IYO ALPINION USA	E-Cube 12	2015-01-29
PMN K142884 | IYN ALPINION USA	E-Cube 12	2015-01-29
PMN K142884 | ITX ALPINION USA	E-Cube 12	2015-01-29
PMN K142733 | IYO ALPINION USA	E-Cube 5	2015-01-29
PMN K142733 | IYN ALPINION USA	E-Cube 5	2015-01-29
PMN K142733 | ITX ALPINION USA	E-Cube 5	2015-01-29
PMN K132687 | IYO ALPINION USA	E-Cube 7	2015-01-29
PMN K132687 | IYN ALPINION USA	E-Cube 7	2015-01-29
PMN K132687 | ITX ALPINION USA	E-Cube 7	2015-01-29
PMN K121937 | IYO ALPINION USA	E-Cube Inno	2013-01-16
PMN K121937 | IYN ALPINION USA	E-Cube Inno	2013-01-16
PMN K121937 | ITX ALPINION USA	E-Cube Inno	2013-01-16
PMN K120060 | IYO ALPINION USA	E-Cube 9	2013-01-16
PMN K120060 | IYN ALPINION USA	E-Cube 9	2013-01-16
PMN K120060 | ITX ALPINION USA	E-Cube 9	2013-01-16