Nikkiso Co L T D

FDA Filings

This page includes the latest FDA filings for Nikkiso 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 EXCHANGE6376DUNS 690542378
FDA Registration(s)
Registration Number8031561
FEI Number3002807721
NameDeno Zachary
Owner & OperatorNIKKISO CO. LTD.
Contact Address20-3 EBISU 4-CHOME,
SHIBUYA-KU JP-13 Tokyo 150-8677 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address206 East 75th Street, Suite 4
New York, NY 10021 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3008229990
FEI Number3008229990
NameDeno Zachary
Owner & OperatorNIKKISO CO. LTD.
Contact Address20-3 EBISU 4-CHOME,
SHIBUYA-KU JP-13 Tokyo 150-8677 JP
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address206 East 75th Street, Suite 4
New York, NY 10021 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number3008786333
FEI Number3008786333
NameNikkiso America, Inc.
Owner & OperatorNIKKISO CO. LTD.
Contact Address20-3 EBISU 4-CHOME,
SHIBUYA-KU JP-13 Tokyo 150-8677 JP
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address7676 Hazard Center Drive, Suite 400
San Diego, CA 92108 US

FDA Filings

Device
Company
DeviceDate
NIKKISO CO.,LTD.
 Blood Tubing Lines for Hemodialysis 2023-09-05
NIKKISO CO.,LTD.
 BLOOD TUBING LINES FOR HEMODIALYSIS 2020-11-09
Deno Zachary [NIKKISO CO. LTD.]
LIPOSORBER LA-15 System2019-03-07
Deno Zachary [NIKKISO CO. LTD.]
LIPOSORBER LA-15 System2019-03-07
NIKKISO CO.,LTD.
 HEMODIALYSIS DELIVERY SYSTEM 2018-07-06
NIKKISO CO.,LTD.
 HEMODIALYSIS DELIVERY SYSTEM 2018-07-06
Deno Zachary [NIKKISO CO. LTD.]
DBB-06 Hemodialysis Delivery System2016-03-24
NIKKISO, CO.,LTD.
DBB-06 Hemodialysis Delivery System2016-03-18
Deno Zachary [NIKKISO CO. LTD.]
Liposorber LA-15 system2013-12-19
Deno Zachary [NIKKISO CO. LTD.]
Liposorber LA-15 system2013-12-19
Deno Zachary [NIKKISO CO. LTD.]
Liposorber LA-15 system2013-02-13
Deno Zachary [NIKKISO CO. LTD.]
Liposorber LA-15 system2013-02-13
Deno Zachary [NIKKISO CO. LTD.]
DBB-06 Hemodialysis Delivery System2010-12-11
Deno Zachary [NIKKISO CO. LTD.]
NIKKLINE Blood Tubing Lines with Transducer protectors2010-12-10
NIKKISO CO. LTD.
DBB-06 HEMODIALYSIS DELIVERY SYSTEM2010-03-25
NIKKISO CO. LTD.
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P2009-03-30
Deno Zachary [NIKKISO CO. LTD.]
Modification to DBB-052008-03-03
Deno Zachary [NIKKISO CO. LTD.]
Hemodialysis Delivery System2008-03-03
NIKKISO CO. LTD.
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM2007-09-28
Deno Zachary [NIKKISO CO. LTD.]
DBB-05 HEMODIALYSIS DELIVERY SYSTEM2006-07-05
NIKKISO CO. LTD.
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS1997-03-19
NIKKISO CO. LTD.
NIKKISO ND-14 PARALLEL FLOW DIALYZER1981-03-04

Related Finance Registrations
NCAGE CodeSWX34NIKKISO CO., LTD.
NCAGE CodeSTW56NIKKISO CO., LTD
NCAGE CodeSP036NIKKISO CO. LTD.
CAGE CodeSP036NIKKISO CO. LTD.
CAGE CodeSTW56NIKKISO CO., LTD
CAGE CodeSWX34NIKKISO CO., LTD.
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092644058Nagoya Ko ,Japan -> Los Angeles, CaliforniaNIKKISO HEMODIALYSIS EQUIPMENT . . . . .4 PCS
2020092552614Tokyo ,Japan -> Los Angeles, CaliforniaPARTS OF AIRCRAFT ENGINES6 CTN
202009218699Pusan,South Korea -> Mobile, AlabamaNIKKISO HEMODIALYSIS EQUIPMENT . . . . . .168 TRI
202009218699Pusan,South Korea -> Mobile, AlabamaNIKKISO HEMODIALYSIS EQUIPMENT . . . . . .168 TRI
202009218699Pusan,South Korea -> Mobile, AlabamaNIKKISO HEMODIALYSIS EQUIPMENT . . . . . .168 TRI
202009218699Pusan,South Korea -> Mobile, AlabamaNIKKISO HEMODIALYSIS EQUIPMENT . . . . . .168 TRI
2020091953097Nagoya Ko ,Japan -> Los Angeles, CaliforniaNIKKISO HEMODIALYSIS EQUIPMENT . . . . .4 PCS
2020091963871Tokyo ,Japan -> Los Angeles, CaliforniaPARTS OF AIRCRAFT ENGINES10 CTN
2020091927812Nagoya Ko ,Japan -> Los Angeles, CaliforniaPARTS FOR HEMODIALYSIS EQUIPMENT (8534.00)1 CAS
2020091813631Tokyo ,Japan -> Los Angeles, CaliforniaNON-SEAL PUMP (8413.70)7 CAS
2020091852320Nagoya Ko ,Japan -> Los Angeles, CaliforniaNIKKISO HEMODIALYSIS EQUIPMENT . . . . .4 PCS
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