Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610987

FEI Number

3002807710

Entity Name

NIPRO CORPORATION ODATE FACTORY

City/State/Country

ODATE-SHI Akita, JP

Establishment Address

8-7, Hanukiyachi, Niida, ODATE-SHI Akita 018-5794, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIPRO CORPORATION (Owner Number: 8030375)

Owner / Operator Contact Address

3-26, Senriokashinmachi, Settsu, JP-27 566-8510, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140191

PMA Number

N/A

All Registered Proprietary Names

NIPRO Cellentia Dialyzer Surdial DX Hemodialysis System and Accessories ELISIO-09H and 25H.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-03-21
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2024-04-02
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-08
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-04-22

Official Correspondent

Nobuhiro Morimoto

US Agent Details

JESSICA OSWALD-MCLEOD Business: NIPRO MEDICAL CORPORATION Email: JessicaO@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

NIPRO CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016250252	SHIBUYA CORPORATION	Kanazawa Ishikawa, JP
3010377171	PT. Nipro Indonesia Jaya	Karawang Jawa Barat, ID
3004138517	NIPRO (SHANGHAI) CO., LTD.	SHANGHAI, CN
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP
1056186	NIPRO MEDICAL CORPORATION	Doral, FL, US

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
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04

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
3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610987. Last updated year: 2026. Please use registration number 9610987 when referencing this establishment in official correspondence.