Asahi Kasei Pharma Corp

FDA Filings

This page includes the latest FDA filings for Asahi Kasei Pharma 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: 3003460426
• FEI Number: 3003460426
• Name: Michael van der Woude
• Owner & Operator: Asahi Kasei Pharma Corporation
• Contact Address: 1-1-2 Yurakucho ; Chiyoda-ku JP-13 Tokyo 100-0006 JP
• Official Correspondent:
  • Akitake Yamashita
  • 81-3-66993617-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Repesentation LLC
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Rd Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

• Registration Number: 8043889
• FEI Number: 3003206796
• Name: Asahi Kasei Pharma Corporation, Ohito
• Owner & Operator: Asahi Kasei Pharma Corporation
• Contact Address: 1-1-2 Yurakucho ; Chiyoda-ku JP-13 Tokyo 100-0006 JP
• Official Correspondent:
  • Akitake Yamashita
  • 81-3-66993617-x
• US Agent:
  • Michael van der Woude
  • Emergo Global Representation LLC
  • 512 3279997
  • USAgent@ul.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 632-1 Mifuku ; Izunokuni City Sizuoka, 410-2321 JP
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04987153301016 ASAHI KASEI PHARMA CORPORATION	Lucica® Glycated Albumin-L GA R-1 L212GA	2019-10-29
GUDID 04987153301061 ASAHI KASEI PHARMA CORPORATION	Control for Lucica® Glycated Albumin-L G282GA	2019-03-11
GUDID 04987153301054 ASAHI KASEI PHARMA CORPORATION	Calibrator for Lucica® Glycated Albumin-L G252GA	2019-03-11
GUDID 04987153301047 ASAHI KASEI PHARMA CORPORATION	Lucica® Glycated Albumin-L ALB R-2 L242GA	2019-03-11
GUDID 04987153301030 ASAHI KASEI PHARMA CORPORATION	Lucica® Glycated Albumin-L ALB R-1 L232GA	2019-03-11
GUDID 04987153301023 ASAHI KASEI PHARMA CORPORATION	Lucica® Glycated Albumin-L GA R-2 L222GA	2019-03-11
PMN K170147 ASAHI KASEI PHARMA CORPORATION	Lucica Glycated Albumin-L	2017-10-12

Related Finance Registrations

NCAGE Code	SHTY2	ASAHI KASEI PHARMA CORPORATION
CAGE Code	SHTY2	ASAHI KASEI PHARMA CORPORATION