Sekisui Medical Co L T D

FDA Filings

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

FDA Registration(s)
Registration Number3003539867
FEI Number3006769061
NameJason Bilobram
Owner & OperatorSEKISUI MEDICAL CO., LTD.
Contact Address1-3, Nihonbashi 2-chome Chuo-ku
Tokyo JP-13 Tokyo 103-0027 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Wall Street
Burlington, MA 01803 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3006786407
FEI Number3002806840
NameJASON BILOBRAM
Owner & OperatorSEKISUI MEDICAL CO., LTD.
Contact Address1-3, Nihonbashi 2-chome Chuo-ku
Tokyo JP-13 Tokyo 103-0027 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressOne Wall Street
Burlington, MA 01803 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Sekisui Medical Co., Ltd.
2020-06-15
Sekisui Medical Co., Ltd.
CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set2018-05-09
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
Lipase Color Activator; Lipase Color Calibrator; Lipase Color Reagent; Lipase Color Solvent2015-01-29
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL-ST CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
N-GENEOUS LDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
LIQUID N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
KIT/CALIBRATOR2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
LIQUID N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
KIT/CALIBRATOR2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
ULTRA N-GENEOUS HDL CHOLESTEROL2008-05-22
Jason Bilobram [SEKISUI MEDICAL CO., LTD.]
ULTRA N-GENEOUS HDL CHOLESTEROL2008-05-22

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019083046831Kobe,Japan -> Los Angeles, CaliforniaHTS 382499 BLOOD COAGULANT ACCELERATOR90 CTN
2019080530885Kobe,Japan -> Los Angeles, CaliforniaHTS 382499 BLOOD COAGULANT ACCELERATOR80 CTN
2019072544408Kobe,Japan -> Los Angeles, CaliforniaHTS 382499 BLOOD COAGULANT ACCELERATOR80 CTN
2019062030668Pusan,South Korea -> Los Angeles, CaliforniaBLOOD COAGULANT ACCELERATOR 1.7% GU366391 PKG
2019050271127Pusan,South Korea -> Los Angeles, CaliforniaBLOOD COAGULANT ACCELERATOR 1.7% GU3630 (65 CARTONS) FREIGHT COLLECT75 PKG
2019041168751Pusan,South Korea -> Los Angeles, CaliforniaBLOOD COAGULANT ACCELERATOR 1.7% GU3630 (65 CARTONS) FREIGHT COLLECT65 PKG
2019030448074Pusan,South Korea -> Long Beach, CaliforniaBLOOD COAGULANT ACCELERATOR 1.7% GU3583 (65 CARTONS) FREIGHT COLLECT60 PKG
2019013046500Pusan,South Korea -> Long Beach, CaliforniaBLOOD COAGULANT ACCELERATOR 1.7% GU3583 (65 CARTONS) FREIGHT COLLECT3 PKG
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