Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027859369

FEI Number

3027859369

Entity Name

M.E.Nikkiso Vietnam Co., Ltd.

City/State/Country

Quang Ngai, VN

Establishment Address

No.8, Road No.7, Viet Nam Singapore Industrial Park, Tho Phong Commune, Quang Ngai 570000, VN

Establishment Type(s)

Manufacture Medical Device

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

K231589

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

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

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
3014638255	NIKKISO CO., LTD.	SHIBUYA-KU Tokyo, JP
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 3027859369. Last updated year: 2026. Please use registration number 3027859369 when referencing this establishment in official correspondence.