Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611446

FEI Number

3002807725

Entity Name

NIPRO MEDICAL INDUSTRIES LTD.

City/State/Country

TATEBAYASHI-SHI Gunma, JP

Establishment Address

2-19-64, MATSUBARA, TATEBAYASHI-SHI Gunma 374-8518, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NIPRO CORPORATION (Owner Number: 8030375)

Owner / Operator Contact Address

3-26, Senriokashinmachi, Settsu, JP-27 566-8510, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Needle Sniper Hydrophilic Guidewire AQUALiner Ophthalmic Needle Safe Touch PSV Winged Infusion Set (with or without filter) Nipro Blood Collection Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZM	Needle, Dental	Dental	Class 1	872.4730	2006-07-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-12-27
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-08
HNM	Needle, Ophthalmic Suturing	Ophthalmic	Class 1	886.4350	2017-05-31
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-09-08
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-11-06
DZM	Needle, Dental	Dental	Class 1	872.4730	2008-02-19

Official Correspondent

Nobuhiro Morimoto

US Agent Details

JESSICA OSWALD-MCLEOD Business: NIPRO MEDICAL CORPORATION Email: JessicaO@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

NIPRO CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016250252	SHIBUYA CORPORATION	Kanazawa Ishikawa, JP
9610987	NIPRO CORPORATION ODATE FACTORY	ODATE-SHI Akita, JP
3010377171	PT. Nipro Indonesia Jaya	Karawang Jawa Barat, ID
3004138517	NIPRO (SHANGHAI) CO., LTD.	SHANGHAI, CN
1056186	NIPRO MEDICAL CORPORATION	Doral, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days

Similar Registrations

Registration Number	Establishment Name	Location
3005416271	C-K DENTAL IND. CO., LTD.	BUCHEON-SI, GYEONGGI-DO, KR
9612124	AIR WATER REALIZE INC.	IWAKI-SHI Fukushima, JP
3000247873	NIPRO CORPORATION	Settsu Osaka, JP
2416455	COLTENE/WHALEDENT INC.	CUYAHOGA FALLS, OH, US
3009307523	BH Medical Products Co., Ltd	Changzhou City Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611446. Last updated year: 2026. Please use registration number 9611446 when referencing this establishment in official correspondence.