Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031561

FEI Number

3002807721

Entity Name

NIKKISO CO., LTD. - SHIZUOKA PLANT

City/State/Country

SHIZUOKA-KEN, JP

Establishment Address

498-1 SHIZUTANI, MAKINOHARA-SHI, SHIZUOKA-KEN 421-0496, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K242155

PMA Number

N/A

All Registered Proprietary Names

LIPOSORBER LA-15 System AV06C-E Blood Tubing Lines for Hemodialysis Liposorber LA-15 system DIALYSATE FILTERS DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PBN	Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients	Unknown	Class f	N/A	2019-03-07
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2023-08-15
PBN	Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients	Unknown	Class f	N/A	2013-12-19
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-08-01

Official Correspondent

No official correspondent registered.

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
3014638255	NIKKISO CO., LTD.	SHIBUYA-KU Tokyo, JP
3027859369	M.E.Nikkiso Vietnam Co., Ltd.	Quang Ngai, VN
3008229990	M. E. NIKKISO CO., LTD.	Bangnumpeo, Chachoengsao, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3008229990	M. E. NIKKISO CO., LTD.	Bangnumpeo, Chachoengsao, TH
8010002	Asahi Kasei Medical MT Corp. Oita Works	OITA-SHI, JP
3031408734	KANEKA CORPORATION TOMATOH PLANT	Tomakomai-city Hokkaido, JP
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
3023981687	Erika of Texas	Pharr, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031561. Last updated year: 2026. Please use registration number 8031561 when referencing this establishment in official correspondence.