Kaneka Medix Corp Kanagawa Plant

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009761573
• FEI Number: 3009761573
• Name: KANEKA MEDIX CORPORATION KANAGAWA PLANT
• Owner & Operator: KANEKA CORP.
• Contact Address: 2-3-18, Nakanoshima, Kita-ku ; Osaka JP-27 Osaka 530-8288 JP
• US Agent:
  • Kazuhiko Inoue
  • KANEKA PHARMA AMERICA LLC
  • 212 7054343
  • 212 7054395
  • kazuhiko.inoue@kaneka.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 225-1 Aza Deguchi, Yamakita Yamakita-machi; Ashigara-Kami-gun Kanagawa, 2580113 JP
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K170247 | OKS KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.]	Lacriflow CL	2017-04-19
PMN K120886 | OKS KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.]	LACRIFLOW	2013-04-05
PMN K121301 | DXE KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.]	Xpress-Way RX (LD)	2012-08-19
PMN K101839 | DXE KANEKA MEDIX CORPORATION KANAGAWA PLANT [KANEKA CORP.]	Xpress-Way RX	2010-10-27