Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014498725

FEI Number

3014498725

Entity Name

NEMOTO NORTH AMERICA, INC.

City/State/Country

North Ridgeville, OH, US

Establishment Address

37160 Sugar Ridge Rd, North Ridgeville, OH 44039, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nemoto North America, Inc. (Owner Number: 10057761)

Owner / Operator Contact Address

37160 Sugar Ridge Road, North Ridgeville, OH 44039, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242212

PMA Number

N/A

All Registered Proprietary Names

TM0539010 TM0539S TM0539L TM0544W Nemoto Disposable Syringe (Kit) TM0539K TM0539AE Disposable Syringe (Kit) TM0539P TM0539M TM0544C TM0539003 TM0544W200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2024-08-28

Official Correspondent

James Farmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nemoto North America, Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

Similar Registrations

Registration Number	Establishment Name	Location
3003786696	IMAXEON PTY LTD	Rydalmere New South Wales, AU
1518293	Liebel-Flarsheim Company LLC	Cincinnati, OH, US
9616990	NEMOTO KYORINDO CO., LTD.	KAWAGUCHI-SHI Saitama, JP
3015309643	Merit Medical UK Limited	Earley Reading, GB
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014498725. Last updated year: 2026. Please use registration number 3014498725 when referencing this establishment in official correspondence.