Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014638255

FEI Number

3014638255

Entity Name

NIKKISO CO., LTD.

City/State/Country

SHIBUYA-KU Tokyo, JP

Establishment Address

20-3 EBISU 4-CHOME,, SHIBUYA-KU Tokyo 150-6022, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NIKKISO CO., LTD. (Owner Number: 8031561)

Owner / Operator Contact Address

20-3 EBISU 4-CHOME,, SHIBUYA-KU, JP-13 150-6022, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230514

PMA Number

N/A

All Registered Proprietary Names

AL-CDC-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) C18SFD-E(U) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AV06C-E Blood Tubing Lines for Hemodialysis Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2025-08-01
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2023-08-15
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2023-10-17

Official Correspondent

Satoko Hina

US Agent Details

Deno Zachary Business: MIC International Email: dzachary@micinternational.com Phone: (917) 3315789

Related Public Records

Same Entity

NIKKISO CO., LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3040314808	NIKKISO CO., LTD. KANAZAWA PLANT	Kanazawa-Shi, Ishikawa, JP
8031561	NIKKISO CO., LTD. - SHIZUOKA PLANT	SHIZUOKA-KEN, JP
3027859369	M.E.Nikkiso Vietnam Co., Ltd.	Quang Ngai, VN
3008229990	M. E. NIKKISO CO., LTD.	Bangnumpeo, Chachoengsao, TH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014638255. Last updated year: 2026. Please use registration number 3014638255 when referencing this establishment in official correspondence.