Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616990

FEI Number

3008918179

Entity Name

NEMOTO KYORINDO CO., LTD.

City/State/Country

KAWAGUCHI-SHI Saitama, JP

Establishment Address

2-12-23 Aoki, Kawaguchi Plant, KAWAGUCHI-SHI Saitama 332-0031, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NEMOTO KYORINDO CO., LTD. (Owner Number: 9043772)

Owner / Operator Contact Address

2-27-20 HONGO, (HONGO CTR. BLDG. 3RD FLOOR), BUNKYO-KU, JP-13 113-0033, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173450

PMA Number

N/A

All Registered Proprietary Names

Dual Shot alpha 7 alpha 7 DSA7 Dual Shot Alpha 7 Rempress Rempress Angiographic Injection System PRESS DUO elite PRESS DUO elite AG

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	2014-07-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2012-10-04
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2018-02-21

Official Correspondent

JIM KNIPFER

US Agent Details

MICHAEL HIEDA Business: NEMOTO MEDICAL U.S., INC. Email: mkh@nemotous.com Phone: (949) 6326183

Related Public Records

Same Entity

NEMOTO KYORINDO CO., LTD.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616990. Last updated year: 2026. Please use registration number 9616990 when referencing this establishment in official correspondence.