Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010061

FEI Number

3002807736

Entity Name

NIHON SEIMITSU SOKKI CO., LTD.

City/State/Country

SHIBUKAWA Gunma, JP

Establishment Address

2508-13 NAKAGO, SHIBUKAWA Gunma 377-0293, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NIHON SEIMITSU SOKKI CO., LTD. (Owner Number: 8010061)

Owner / Operator Contact Address

2508-13 NAKAGO, SHIBUKAWA, GUNMA, JP-NOTA 377-0293, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Uro Checker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXR	Urinometer, Mechanical	Gastroenterology, Urology	Class 2	876.1800	2023-07-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-19

Official Correspondent

HIDEKI SATO

US Agent Details

FLORENCE ROSTAMI Business: FLORENCE ROSTAMI LAW, LLC Email: frostami@rostamilaw.com Phone: (212) 2093962

Related Public Records

Same Entity

NIHON SEIMITSU SOKKI CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
3023229466	ISHIDA MEDICAL LLC	Irvine, CA, US
9612030	Cardinal Health (Kenmex Medical Specialties)	TIJUANA Baja California, MX
1921846	Cardinal Health	Hazelwood, MO, US
3006082230	C.R. BARD, INC.	MADISON, GA, US
3006061749	FLEXICARE MEDICAL (DONGGUAN) LTD.	DONGGUAN CITY Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010061. Last updated year: 2026. Please use registration number 8010061 when referencing this establishment in official correspondence.