Seikagaku Corp

FDA Filings

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

JAPAN

TOKYO STOCK EXCHANGE

4548

DUNS 690584057

FDA Registration(s)

• Registration Number: 9612392
• FEI Number: 1000255210
• Name: SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• Owner & Operator: SEIKAGAKU CORPORATION
• Contact Address: 6-1, MARUNOUCHI 1-CHOME, CHIYODA-KU; TOKYO JP-NOTA 100-0005 JP
• Official Correspondent:
  • Hiroshi - Murase
  • 81-3-5220-8950
• US Agent:
  • Robert Hoegle
  • NELSON MULLINS RILEY & SCARBOROUGH LLP
  • 202 7122800
  • 202 7122836
  • bob.hoegle@nelsonmullins.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 258-5, AZA-MATSUKUBO OAZA-AKAHAMA; TAKAHAGI-SHI Ibaraki, 318-0001 JP
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P980044S058 SEIKAGAKU CORP.	SUPARTZ FX, VISCO-3	2021-11-17
PMA P080020S046 SEIKAGAKU CORP.	Gel-One	2021-11-17
PMA P080020S045 SEIKAGAKU CORP.	GEL-ONE	2021-10-04
PMA P980044S057 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2021-08-06
PMA P080020S044 SEIKAGAKU CORP.	Gel-One	2021-08-06
PMA P080020S043 SEIKAGAKU CORP.	Gel-One	2021-05-26
PMA P980044S056 SEIKAGAKU CORP.	SUPARTZ device family, SUPARTZ FX and VISCO-3	2021-05-24
PMA P980044S055 SEIKAGAKU CORP.	SUPARTZ device family, SUPARTZ FX and VISCO-3	2021-04-15
PMA P080020S042 SEIKAGAKU CORP.	Gel-One	2021-04-15
PMA P080020S040 SEIKAGAKU CORP.	Gel-One	2020-11-17
PMA P980044S054 SEIKAGAKU CORP.	SUPARTZ FX, VISCO-3	2020-11-12
PMA P080020S039 SEIKAGAKU CORP.	Gel-One	2020-11-12
GUDID M717715644440 SEIKAGAKU CORPORATION	SUPARTZ FX sodium hyaluronate 7156-4444	2020-08-06
PMA P980044S053 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2020-07-17
PMA P080020S038 SEIKAGAKU CORP.	Gel-One	2020-07-17
GUDID 04987541300911 SEIKAGAKU CORPORATION	Gel-One® Cross-linked Hyaluronate 00-1111-001-00	2020-04-20
PMA P080020S037 SEIKAGAKU CORP.	Gel-One	2020-03-31
GUDID 00087541300912 SEIKAGAKU CORPORATION	Gel-One® Cross-linked Hyaluronate 00-1111-001-00	2020-03-25
PMA P080020S036 SEIKAGAKU CORP.	Gel-One	2020-03-16
PMA P080020S035 SEIKAGAKU CORP.	Gel-One	2019-10-30
PMA P080020S033 SEIKAGAKU CORP.	Gel-One	2019-03-13
PMA P080020S032 SEIKAGAKU CORP.	Gel-One	2019-03-13
GUDID 04987541301314 SEIKAGAKU CORPORATION	VISCO-3 sodium hyaluronate 00-1111-001-03	2019-02-18
PMA P980044S051 SEIKAGAKU CORP.	SUPARTZ FX; VISCO-3	2019-01-18
PMA P980044S050 SEIKAGAKU CORP.	Supartz FX and Visco-3	2018-12-06
PMA P080020S031 SEIKAGAKU CORP.	Gel-One	2018-12-06
PMA P980044S049 SEIKAGAKU CORP.	SUPARTZ FX/VISCO-3	2018-11-13
PMA P980044S047 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2018-08-16
PMA P980044S048 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2018-08-07
PMA P080020S030 SEIKAGAKU CORP.	Gel-One	2018-08-07
PMA P980044S046 SEIKAGAKU CORP.	Supartz FX, Visco-3	2018-06-08
PMA P980044S045 SEIKAGAKU CORP.	Supartz FX, Visco-3	2018-05-25
PMA P980044S039 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2018-03-15
PMA P080020S026 SEIKAGAKU CORP.	GEL-ONE	2018-03-15
PMA P980044S043 SEIKAGAKU CORP.	Supartz FX and Visco-3	2018-03-14
PMA P080020S029 SEIKAGAKU CORP.	Gel-One	2018-03-14
PMA P980044S042 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2018-02-09
PMA P080020S028 SEIKAGAKU CORP.	Gel-One	2018-02-09
PMA P980044S041 SEIKAGAKU CORP.	SUPARTZ FX / VISCO-3	2017-12-14
PMA P080020S027 SEIKAGAKU CORP.	Gel-One	2017-12-14
PMA P980044S040 SEIKAGAKU CORP.	SUPARTZ FX and VISCO-3	2017-07-28
PMA P980044S038 SEIKAGAKU CORP.	Supartz FX and Visco-3	2017-03-29
PMA P980044S037 SEIKAGAKU CORP.	Supartz Family	2017-03-21
PMA P080020S025 SEIKAGAKU CORP.	Gel-One	2017-03-21
PMA P980044S036 SEIKAGAKU CORP.	SUPARTZ FX & VISCO-3	2017-01-19
PMA P080020S024 SEIKAGAKU CORP.	GEL-ONE	2017-01-19
PMA P080020S023 SEIKAGAKU CORP.	GEL-ONE	2016-12-19
PMA P080020S022 SEIKAGAKU CORP.	GEL-ONE	2016-11-23
PMA P080020S020 SEIKAGAKU CORP.	GEL-ONE(R)	2016-09-27
PMA P980044S035 SEIKAGAKU CORP.	SUPARTZ FX VISCO-3	2016-09-14
PMA P980044S034 SEIKAGAKU CORP.	SUPARTZ FX, VISCO-3	2016-09-13
PMA P080020S021 SEIKAGAKU CORP.	GEL-ONE	2016-07-25
PMA P980044S032 SEIKAGAKU CORP.	SUPARTZ FX	2016-05-13
PMA P080020S008 SEIKAGAKU CORP.	GEL-ONE	2016-03-29
PMA P980044S031 SEIKAGAKU CORP.	SUPARTZ FX	2016-03-22
PMA P080020S019 SEIKAGAKU CORP.	GEL-ONE	2016-03-22
PMA P980044S028 SEIKAGAKU CORP.	SUPARTZ FX	2016-01-27
PMA P980044S030 SEIKAGAKU CORP.	SUPARTZ FX	2016-01-06
PMA P980044S027 SEIKAGAKU CORP.	VISCO-3	2015-12-21
PMA P980044S029 SEIKAGAKU CORP.	SUPARTZ FX	2015-12-10
PMA P080020S018 SEIKAGAKU CORP.	GEL-ONE	2015-11-25
PMA P080020S017 SEIKAGAKU CORP.	GEL-ONE	2015-08-28
PMA P080020S016 SEIKAGAKU CORP.	GEL-ONE	2015-08-28
PMA P080020S014 SEIKAGAKU CORP.	GEL-ONE	2015-08-03
PMA P980044S026 SEIKAGAKU CORP.	SUPARTZ FX	2015-07-16
PMA P080020S015 SEIKAGAKU CORP.	GEL-ONE	2015-07-16
PMA P980044S025 SEIKAGAKU CORP.	SUPARTZ FX	2015-05-20
PMA P980044S024 SEIKAGAKU CORP.	SUPARTZ	2015-03-31
PMA P980044S023 SEIKAGAKU CORP.	SUPARTZ	2014-12-17
PMA P980044S022 SEIKAGAKU CORP.	SUPARTZ	2014-12-17
PMA P980044S021 SEIKAGAKU CORP.	SUPARTZ	2014-12-17
PMA P980044S020 SEIKAGAKU CORP.	SUPARTZ	2014-12-17
PMA P080020S013 SEIKAGAKU CORP.	GEL-ONE	2014-10-30
PMA P980044S019 SEIKAGAKU CORP.	SUPARTZ	2014-09-26
PMA P080020S012 SEIKAGAKU CORP.	GEL-ONE	2014-08-28
PMA P080020S011 SEIKAGAKU CORP.	GEL-ONE	2014-08-28
PMA P080020S010 SEIKAGAKU CORP.	GEL ONE	2014-08-28
PMA P080020S009 SEIKAGAKU CORP.	GEL-ONE	2014-08-25
PMA P980044S018 SEIKAGAKU CORP.	SUPARTZ	2014-05-30
PMA P080020S007 SEIKAGAKU CORP.	GEL-ONE	2014-05-30
PMA P980044S017 SEIKAGAKU CORP.	SUPARTZ	2014-01-14
PMA P080020S006 SEIKAGAKU CORP.	GEL-ONE	2013-10-11
PMA P080020S005 SEIKAGAKU CORP.	GEL-ONE	2013-08-23
PMA P980044S016 SEIKAGAKU CORP.	SUPARTZ	2013-07-25
PMA P980044S015 SEIKAGAKU CORP.	SUPARTZ	2013-07-12
PMA P080020S004 SEIKAGAKU CORP.	GEL-ONE	2012-11-30
PMA P080020S003 SEIKAGAKU CORP.	GEL-ONE	2012-11-01
PMA P080020S002 SEIKAGAKU CORP.	GEL-ONE	2012-10-10
PMA P980044S014 SEIKAGAKU CORP.	SUPARTZ	2012-09-18
PMA P980044S013 SEIKAGAKU CORP.	SUPARTZ	2012-05-04
PMA P080020S001 SEIKAGAKU CORP.	GEL-ONE	2012-05-04
PMN P080020 | MOZ SEIKAGAKU CORPORATION, TAKAHAGI PLANT [SEIKAGAKU CORPORATION]	Gel-One	2011-09-12
PMA P080020 SEIKAGAKU CORP.	GEL-ONE	2011-03-22
PMA P980044S012 SEIKAGAKU CORP.	SUPARTZ	2010-10-19
PMA P980044S010 SEIKAGAKU CORP.	SUPARTZ	2009-09-25
PMA P980044S009 SEIKAGAKU CORP.	SUPARTZ JOINT FLUID THERAPY	2009-07-08
PMA P980044S007 SEIKAGAKU CORP.	SUPARTZ	2009-07-07
PMA P980044S008 SEIKAGAKU CORP.	SUPARTZ	2008-08-29
PMN P980044 | MOZ SEIKAGAKU CORPORATION, TAKAHAGI PLANT [SEIKAGAKU CORPORATION]	VISCO-3	2007-12-17
PMN P980044 | MOZ SEIKAGAKU CORPORATION, TAKAHAGI PLANT [SEIKAGAKU CORPORATION]	SUPARTZ FX	2007-12-17
PMA P980044S006 SEIKAGAKU CORP.	SUPARTZ	2007-03-07
PMA P980044S005 SEIKAGAKU CORP.	SUPARTZ	2007-02-13
PMN K011544 SEIKAGAKU CORP.	HADGEL, 4 GRAM/SYRINGE	2001-08-15

Similar & Related FDA Registered Companies

• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS051 Date Received12/08/2022 Decision Date01/05/2023 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS049 Date Received09/20/2022 Decision Date10/19/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS048 Date Received06/22/2022 Decision Date07/22/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP980044 Supplement NumberS059 Date Received03/02/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• SEIKAGAKU CORP.6-1, Marunouchi 1-chome,chiyoda-kutokyo 100-0-0005 PMA NumberP080020 Supplement NumberS047 Date Received03/03/2022 Decision Date03/31/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	SYP84	SEIKAGAKU CORPORATION
NCAGE Code	SP489	SEIKAGAKU CORP.
CAGE Code	SP489	SEIKAGAKU CORP.
CAGE Code	SYP84	SEIKAGAKU CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092555454	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	382 CTN
2020092555454	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	382 CTN
2020081523119	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PACKING BOX AND RUBBER STOPPER HS CODE:4016.99	83 CTN
2020081222281	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020081222281	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080830367	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080830367	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080143262	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020080143262	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020072452907	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020072452907	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020070833707	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020070833707	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020062651681	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN
2020062651681	Tokyo ,Japan -> Los Angeles, California	EXTRACTS OF GLANDS OR OTHER ORGANS OR SECRET	381 CTN