Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8041145

FEI Number

3002974635

Entity Name

Nipro (Thailand) Corporation Limited

City/State/Country

SENA Phra Nakhon Si Ayutthaya, TH

Establishment Address

10/2 Moo 8, Bangnomko,, SENA Phra Nakhon Si Ayutthaya 13110, TH

Establishment Type(s)

Manufacture Medical Device

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

K113471

PMA Number

N/A

All Registered Proprietary Names

Syringe, Piston NIPRO SAFETOUCH IV CATHETER winged NIPRO SAFETOUCH IV CATHETER Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set NIPRO Transducer Protector TP-SURE Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle Surdial DX Hemodialysis System and Accessories NIPRO BioHole Needle with CAPICK Scab Remover BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Hold

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2006-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2006-11-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2017-03-21
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2012-11-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-05
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2008-03-31
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-12-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-12-01
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	2012-11-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2008-02-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-02-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-09-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-20
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-08
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2010-04-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-04-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-11-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2026-06-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2026-06-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-09-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2008-01-08
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-11-20

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
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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3009249481	JMS Co.,Ltd. Miyoshi Plant	Miyoshi Hiroshima, JP
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8041145. Last updated year: 2026. Please use registration number 8041145 when referencing this establishment in official correspondence.