CITIZEN SYSTEMS (JIANGMEN) CO., LTD.

FDA Device Registration & Listing · JIANGMEN CITY Guangdong, CN · Registration 3005290115

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005290115
FEI Number
3005290115
Entity Name
CITIZEN SYSTEMS (JIANGMEN) CO., LTD.
City/State/Country
JIANGMEN CITY Guangdong, CN
Establishment Address
399 Jinxing Road, JIANGMEN CITY Guangdong --, CN
Establishment Type(s)
Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
K093931
PMA Number
N/A

All Registered Proprietary Names

CH-308B Citizen Systems CH-456 Citizen Systems CH-452 Citizen Systems CH-4532 Citizen Systems CH-453

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2010-06-21

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Beaver Business: FOLEY & LARDNER LLP 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
8031509 CITIZEN SYSTEMS JAPAN CO., LTD. NISHI-TOKYO-SHI, JP

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005290115. Last updated year: 2026. Please use registration number 3005290115 when referencing this establishment in official correspondence.
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