Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031408734

FEI Number

3031408734

Entity Name

KANEKA CORPORATION TOMATOH PLANT

City/State/Country

Tomakomai-city Hokkaido, JP

Establishment Address

6-253, Aza Kashiwabara, Tomakomai-city Hokkaido 059-1362, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

KANEKA CORP. (Owner Number: 9005249)

Owner / Operator Contact Address

2-3-18, Nakanoshima, Kita-ku, Osaka, JP-27 530-8288, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H120005

All Registered Proprietary Names

Liposorber LA-15 system Liposorber LA-15 System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMY	Lipoprotein, Low Density, Removal	Unknown	Class 3	N/A	2007-10-16
PBN	Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients	Unknown	Class f	N/A	2013-11-01

Official Correspondent

Takeaki Miyata

US Agent Details

Audra Bogucki Email: audra.bogucki@kaneka.com Phone: (917) 6289870

Related Public Records

Same Entity

KANEKA CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009761573	KANEKA MEDIX CORPORATION KANAGAWA PLANT	Ashigara-Kami-gun Kanagawa, JP
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
3031550970	KANEKA MEDICAL VIETNAM Co.,Ltd.	Ho Chi Minh, VN

Similar Registrations

Registration Number	Establishment Name	Location
3008229990	M. E. NIKKISO CO., LTD.	Bangnumpeo, Chachoengsao, TH
9614654	Kaneka Corporation Osaka Plant	Settsu-shi Osaka, JP
8010002	Asahi Kasei Medical MT Corp. Oita Works	OITA-SHI, JP
8031561	NIKKISO CO., LTD. - SHIZUOKA PLANT	SHIZUOKA-KEN, JP
3031365458	WOMED SAS	Montpellier Herault, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031408734. Last updated year: 2026. Please use registration number 3031408734 when referencing this establishment in official correspondence.