Asahi Kasei Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Asahi Kasei 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 Number3009960884
FEI Number3009960884
NameMauricio Pineda
Owner & OperatorAsahi Kasei Medical Co., Ltd.
Contact Address1-1-2 Yurakucho
Chiyoda-ku JP-13 Tokyo 100-0006 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1855 Elmdale Avenue
Glenview, IL 60026 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3007340888
FEI Number3007340888
NameAsahi Kasei Medical MT Corp. Okatomi Plant
Owner & OperatorAsahi Kasei Medical Co., Ltd.
Contact Address1-1-2 Yurakucho
Chiyoda-ku JP-13 Tokyo 100-0006 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5-4960 NAKAGAWARA-MACHI
NOBEOKA-SHI Miyazaki, 882-0031 JP
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number8010002
FEI Number3002806407
NameMauricio Pineda
Owner & OperatorAsahi Kasei Medical Co., Ltd.
Contact Address1-1-2 Yurakucho
Chiyoda-ku JP-13 Tokyo 100-0006 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1855 Elmdale Avenue
Glenview, IL 60026 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Sterilize Medical Device for Another Party (Contract Sterilizer)



FDA Filings

Device
Company
DeviceDate
Asahi Kasei Medical Co., Ltd.
Plasmaflo OP-05W(A)2020-10-22
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
Liposorber LA-15 system2018-06-21
Asahi Kasei Medical Co., Ltd.
Plasmaflo OP-05W(A)2018-02-15
Asahi Kasei Medical Co., Ltd.
Plasmaflo2018-01-17
ASAHI KASEI MEDICAL CO., LTD.
Asahi ViE-U Series Dialyzer2017-05-03
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
REXEED-S SERIES DIALYZERS2016-05-12
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
REXEED-S SERIES DIALYZERS2016-05-12
Asahi Kasei Medical MT Corp. Okatomi Plant [Asahi Kasei Medical Co., Ltd.]
REXEED-S SERIES DIALYZERS2016-05-12
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR2016-03-09
Asahi Kasei Medical Co., Ltd.
Asahi REXEED-S Series Dialyzer2015-12-17
Asahi Kasei Medical Co., Ltd.
PLASMAFLO2015-12-03
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
Liposorber LA-15 system2013-11-19
ASAHI KASEI MEDICAL CO., LTD.
ASAHI REXEED-SX/LX SERIES DIALYZER2013-02-06
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
Liposorber LA-15 system2013-01-30
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
Plasmaflo OP-05W(A)2012-04-10
Mauricio Pineda [Asahi Kasei Medical Co., Ltd.]
Plasmaflo OP-05W(A)2012-04-10
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05W (A)2011-11-02
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05W (A)2011-01-28
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05W(A)2010-08-06
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05W (A)2010-03-16
ASAHI KASEI MEDICAL CO., LTD.
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX2008-10-03
ASAHI KASEI MEDICAL CO., LTD.
REXEED SERIES DIALYZERS2005-06-08
Asahi Kasei Medical Co., Ltd.
PLASMAFLO AP-05H ASAHI PLASMA SEPARATOR1986-01-08
Asahi Kasei Medical Co., Ltd.
PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR1983-07-05

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092457211Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS369 CTN
2020092172088Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS369 CTN
2020091976538Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS369 CTN
2020082855847Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS366 CTN
2020082759453Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS366 CTN
2020082471796Puerto Manzanillo,Panama -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS366 CTN
2020081071308Manzanillo,Mexico -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS610 CTN
2020072778667Manzanillo,Mexico -> San Juan, Puerto RicoLEUCOCYTE REDUCTION FILTERS476 CTN

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