Nipro Corp

FDA Filings

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

JAPANTOKYO STOCK EXCHANGE8086DUNS 690555453
FDA Registration(s)
Registration Number3004138517
FEI Number3004138517
NameGOICHI MIYAZUMI
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3150 NW 107 AVE..
MIAMI, FL 33172 US
Establishment TypeManufacture Medical Device



Registration Number8041145
FEI Number3002974635
NameNipro (Thailand) Corporation Limited
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address10/2 Moo 8, Bangnomko,
SENA Phra Nakhon Si Ayutthaya, 13110 TH
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3000247873
FEI Number3000247873
NameGOICHI MIYAZUMI
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3150 NW 107 AVE. MIAMI
Doral, FL 33172 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



Registration Number3016250252
FEI Number3016250252
NameGOICHI MIYAZUMI
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3150 NW 107 AVE.
Miami, FL 33172 US
Establishment TypeManufacture Medical Device



Registration Number9611446
FEI Number3002807725
NameGOICHI MIYAZUMI
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3150 NW 107 AVE.
MIAMI, FL 33172 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number1056186
FEI Number1000132332
NameNIPRO MEDICAL CORPORATION
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address3150 NW 107TH AVE
Doral, FL 33172 US



Registration Number9610987
FEI Number3002807710
NameNIPRO CORP.
Owner & OperatorNIPRO CORPORATION
Contact Address3-9-3, Honjo-Nishi, Kita-Ku --
Osaka JP-27 Osaka 531-8510 JP
Official Correspondent
  • Tadao Kobayashi
  • 81-6-63756739-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8-7, HANUKIYACHI, NIIDA,
ODATE-SHI Akita, 018-5794 JP
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
Sato Pharmaceutical Co., Ltd., Nipro Corporation
Otc Medication2023-11-04
Sato Pharmaceutical Co., Ltd., Nipro Corporation
Otc Medication2023-08-23
Sato Pharmaceutical Co., Ltd., Nipro Corporation
Otc Medication2022-01-14
Sato Pharmaceutical Co., Ltd., Nipro Corporation
Otc Medication2020-11-02
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Surdial DX Hemodialysis System and Accessories2019-09-08
NIPRO CORP. [NIPRO CORPORATION]
Surdial DX Hemodialysis System and Accessories2019-09-08
GOICHI MIYAZUMI [NIPRO CORPORATION]
Surdial DX Hemodialysis System and Accessories2019-09-08
GOICHI MIYAZUMI [NIPRO CORPORATION]
Surdial DX Hemodialysis System and Accessories2019-09-08
GOICHI MIYAZUMI [NIPRO CORPORATION]
Ophthalmic Needle2017-05-31
GOICHI MIYAZUMI [NIPRO CORPORATION]
Ophthalmic Needle2017-05-31
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
NIPRO SAFETOUCH IV CATHETER2017-03-21
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
NIPRO SAFETOUCH IV CATHETER winged2017-03-21
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO SAFETOUCH IV CATHETER2017-03-21
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO SAFETOUCH IV CATHETER winged2017-03-21
NIPRO CORP. [NIPRO CORPORATION]
NIPRO Cellentia Dialyzer2017-03-21
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO Cellentia Dialyzer2017-03-21
GOICHI MIYAZUMI [NIPRO CORPORATION]
Safe Touch PSV Winged Infusion Set (with or without filter)2014-09-08
GOICHI MIYAZUMI [NIPRO CORPORATION]
Safe Touch PSV Winged Infusion Set (with or without filter)2014-09-08
NIPRO CORP. [NIPRO CORPORATION]
ELISIO-09H and 25H.2014-04-22
GOICHI MIYAZUMI [NIPRO CORPORATION]
ELISIO-09H and 25H.2014-04-22
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch PSV Scalp Vein Set with Safety Device2014-02-19
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch PSV Scalp Vein Set with Safety Device2014-02-19
NIPRO CORP. [NIPRO CORPORATION]
ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M.2014-01-30
GOICHI MIYAZUMI [NIPRO CORPORATION]
ELISIO-11H, 13H, 15H, 17H, 19H and 21H. ELISIO-11M, 13M, 15M, 17M, 19M and 21M.2014-01-30
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set2012-11-22
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set2012-11-22
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Scab Remover2010-04-13
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
NIPRO BioHole Needle with CAPICK2010-04-13
GOICHI MIYAZUMI [NIPRO CORPORATION]
Scab Remover2010-04-13
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO BioHole Needle with CAPICK2010-04-13
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
NIPRO Transducer Protector TP-SURE2008-03-31
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO Transducer Protector TP-SURE2008-03-31
GOICHI MIYAZUMI [NIPRO CORPORATION]
Sniper Hydrophilic Guidewire2007-11-20
GOICHI MIYAZUMI [NIPRO CORPORATION]
Sniper Hydrophilic Guidewire2007-11-20
GOICHI MIYAZUMI [NIPRO CORPORATION]
AQUALiner2007-11-20
GOICHI MIYAZUMI [NIPRO CORPORATION]
AQUALiner2007-11-20
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
NIPRO A.V. FISTULA NEEDLE2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO A.V. FISTULA NEEDLE2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro Scalp Vein Set2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Scalp Vein Set2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro blood tubing set2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro blood tubing set2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch TULIP Safety AVF2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch II Gamma2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch II Gamma2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch II Safety AVF2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch II Safety AVF2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch Safety BCS2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch Safety BCS2007-11-15
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Nipro SafeTouch Safety BCS2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro SafeTouch Safety BCS2007-11-15
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Blood Collection Needle2006-11-06
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Blood Collection Needle2006-11-06
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Syringe, Piston2006-11-06
GOICHI MIYAZUMI [NIPRO CORPORATION]
Syringe, Piston2006-11-06
Nipro (Thailand) Corporation Limited [NIPRO CORPORATION]
Syringe, Piston2006-11-06
GOICHI MIYAZUMI [NIPRO CORPORATION]
Syringe, Piston2006-11-06
GOICHI MIYAZUMI [NIPRO CORPORATION]
Dental Needle2006-07-12
GOICHI MIYAZUMI [NIPRO CORPORATION]
Dental Needle2006-07-12
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Hydrophilic Guidewire2006-03-30
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Hydrophilic Guidewire2006-03-30
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO HYDROPHILIC FOR UR2006-03-30
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO HYDROPHILIC FOR UR2006-03-30
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Hypodermic Needle2005-12-16
GOICHI MIYAZUMI [NIPRO CORPORATION]
Nipro Hypodermic Needle2005-12-16
GOICHI MIYAZUMI [NIPRO CORPORATION]
Needle2004-04-16
GOICHI MIYAZUMI [NIPRO CORPORATION]
Needle2004-04-16
NIPRO CORP. [NIPRO CORPORATION]
NIPRO SAFELET CATH2001-01-18
GOICHI MIYAZUMI [NIPRO CORPORATION]
NIPRO SAFELET CATH2001-01-18

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092928523Tokyo ,Japan -> Savannah, GeorgiaBLOOD COLLECTION NEEDLE1271 CTN
2020092824400Pusan,South Korea -> New York/Newark Area, Newark, New JerseyDIALYZER1260 CTN
2020092541281Tokyo ,Japan -> Oakland, CaliforniaCATHETERS575 CTN
2020092163234Pusan,South Korea -> Los Angeles, CaliforniaSHIPPER'S LOAD & COUNT 1X40'HC CONTAINER 1320 CARTONS ================================== DIALYZER CARGO RECEIVER:HENRY SCHEIN C/O CDC CUSTOMER'S PO# 186366001320 CTN
2020092162239Tokyo ,Japan -> Los Angeles, CaliforniaMEDICAL GOODS60 CTN
2020092127771Tokyo ,Japan -> Charleston, South CarolinaBLOOD COLLECTION NEEDLES477 CTN
2020091967670Tokyo ,Japan -> Los Angeles, CaliforniaBLOOD COLLECTION NEEDLE253 CTN
2020091916157Shanghai ,China (Mainland) -> Savannah, GeorgiaMEDICAL GOODS450 CTN

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