Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044778332

FEI Number

3044778332

Entity Name

SHINCOTEC CO., LTD.

City/State/Country

Kawagoe Saitama, JP

Establishment Address

1-16-21 Nakadaimotomachi, Kawagoe Saitama 3501138, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shincotec Co., Ltd. (Owner Number: 10095654)

Owner / Operator Contact Address

1-16-21 Nakadaimotomachi, Kawagoe, JP-11 3501138, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2026-04-15

Official Correspondent

Mitsuru Sameshima

US Agent Details

Nozomi Yagi Business: Nipro Vascular Innovations Americas, Inc. Email: RegulatoryNVIA@nipromed.com Phone: (888) 6807339

Related Public Records

Same Entity

Shincotec Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3044778332. Last updated year: 2026. Please use registration number 3044778332 when referencing this establishment in official correspondence.