Eiken Chemical Co L T D

FDA Filings

This page includes the latest FDA filings for Eiken Chemical Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

JAPANTOKYO STOCK EXCHANGE4549DUNS 690640586
FDA Registration(s)
Registration Number3007114058
FEI Number3007114058
NameEiken Chemical Co., Ltd. Nasu Plant
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1381-3, Shimoishigami
Ohtawara-shi Totigi, 324-0036 JP
Establishment TypeManufacture Medical Device

Registration Number9611917
FEI Number3009431614
NameEIKEN CHEMICAL CO., LTD.
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4-19-9, Taito
Taito-ku Tokyo, 110-8408 JP
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

Registration Number3005610352
FEI Number3002806884
NameEIKEN CHEMICAL CO., LTD. NOGI PLANT
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address143 NOGI NOGI-MACHI,
SHIMOTSUGA-GUN Totigi, 329-0114 JP
Establishment TypeManufacture Medical Device

Registration Number3010391795
FEI Number3010391795
NameMichael Van Der Woude
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3010392456
FEI Number3010392456
NameMichael Van Der Woude
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3007114066
FEI Number3007114066
NameMichael van de Woude
Owner & OperatorEIKEN CHEMICAL CO., LTD.
Contact Address4-19-9, Taito --
Taito-ku JP-13 Tokyo 110-8408 JP
Official Correspondent
  • Tadashi - Yasuda
  • 81-3-58463479-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
Michael Van Der Woude [EIKEN CHEMICAL CO., LTD.]
OC-Auto Sensor io iFOB Test2020-01-05
Michael Van Der Woude [EIKEN CHEMICAL CO., LTD.]
OC-Auto Sensor io iFOB Test2020-01-05
Eiken Chemical Co., Ltd. Nasu Plant [EIKEN CHEMICAL CO., LTD.]
OC-Auto Sensor io iFOB Test2020-01-05
EIKEN CHEMICAL CO., LTD.
OC-Auto Sensor io iFOB Test2020-01-05
EIKEN CHEMICAL CO., LTD. NOGI PLANT [EIKEN CHEMICAL CO., LTD.]
OC-Auto Sensor io iFOB Test2020-01-05
Eiken Chemical Co., Ltd.
OC-Auto SENSOR Io IFOB Test2020-01-02
Michael van de Woude [EIKEN CHEMICAL CO., LTD.]
OC-Light S FIT2015-09-14
EIKEN CHEMICAL CO., LTD.
OC-Light S FIT2015-09-14
EIKEN CHEMICAL CO., LTD. NOGI PLANT [EIKEN CHEMICAL CO., LTD.]
OC-Light S FIT2015-09-14
EIKEN CHEMICAL CO. LTD
OC-Light S FIT2015-08-20
Michael van de Woude [EIKEN CHEMICAL CO., LTD.]
BIOPSY BAG2013-02-13
EIKEN CHEMICAL CO., LTD.
BIOPSY BAG2013-02-13
Eiken Chemical Co., Ltd. Nasu Plant [EIKEN CHEMICAL CO., LTD.]
OC-Sensor DIANA iFOB Test2010-02-05
EIKEN CHEMICAL CO., LTD.
OC-Sensor DIANA iFOB Test2010-02-05
EIKEN CHEMICAL CO., LTD. NOGI PLANT [EIKEN CHEMICAL CO., LTD.]
OC-Sensor DIANA iFOB Test2010-02-05
EIKEN CHEMICAL CO., LTD.
OC-SENSOR DIANA IFOB TEST2010-01-08
Michael van de Woude [EIKEN CHEMICAL CO., LTD.]
OC-Light2008-02-01
EIKEN CHEMICAL CO., LTD.
OC-Light2008-02-01
EIKEN CHEMICAL CO., LTD. NOGI PLANT [EIKEN CHEMICAL CO., LTD.]
OC-Light2008-02-01
Michael Van Der Woude [EIKEN CHEMICAL CO., LTD.]
OC-Auto Micro 80 FOB Test2008-01-09
Michael Van Der Woude [EIKEN CHEMICAL CO., LTD.]
OC-Auto Micro 80 FOB Test2008-01-09
Eiken Chemical Co., Ltd. Nasu Plant [EIKEN CHEMICAL CO., LTD.]
OC-Auto Micro 80 FOB Test2008-01-09
EIKEN CHEMICAL CO., LTD.
OC-Auto Micro 80 FOB Test2008-01-09
EIKEN CHEMICAL CO., LTD. NOGI PLANT [EIKEN CHEMICAL CO., LTD.]
OC-Auto Micro 80 FOB Test2008-01-09

Related Finance Registrations
NCAGE CodeS7702EIKEN CHEMICAL CO. LTD
CAGE CodeS7702EIKEN CHEMICAL CO. LTD
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