Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031509

FEI Number

3005176386

Entity Name

CITIZEN SYSTEMS JAPAN CO., LTD.

City/State/Country

NISHI-TOKYO-SHI, JP

Establishment Address

6-1-12, TANASHI-CHO, NISHI-TOKYO-SHI 188-8511, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CITIZEN SYSTEMS JAPAN CO., LTD. (Owner Number: 8031509)

Owner / Operator Contact Address

6-1-12, Tanashi-cho, --, Nishi-Tokyo-shi, JP-13 188-8511, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033043

PMA Number

N/A

All Registered Proprietary Names

Citizen Systems Japan CTA301, CTA302, CTA303 Citizen Systems CH-650 Citizen Systems CH-657 Citizen Systems CH-456 Citizen Systems CH-452 Citizen Systems CH-4532 Citizen Systems CH-453 CH-308B Citizen Systems Japan CH607 Citizen Systems Japan CH-618 Citizen Systems Japan CH-617

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-09-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2010-06-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-08-08
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2008-04-11

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Beaver Business: FOLEY & LARDNER Email: nbeaver@FOLEY.COM Phone: (202) 6725300

Related Public Records

Same Entity

CITIZEN SYSTEMS JAPAN 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
3005290115	CITIZEN SYSTEMS (JIANGMEN) CO., LTD.	JIANGMEN CITY Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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

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3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031509. Last updated year: 2026. Please use registration number 8031509 when referencing this establishment in official correspondence.