Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006543075

FEI Number

3006543075

Entity Name

SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI

City/State/Country

SHANGHAI, CN

Establishment Address

No. 133 Economic & Trading Center, Xiao Kun Shan Twon,, SHANGHAI 201616, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI (Owner Number: 9092960)

Owner / Operator Contact Address

FL.3 789 Wufang Road,Wujiang district, Suzhou City, Jiangsu Province., Suzhou, CN-JS 215222, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062893

PMA Number

N/A

All Registered Proprietary Names

KODEA KD-202A KD-202F-W XJ-2002AS XJ-2003CS KD-202FV XJ-2001AC XJ-2002AS-1 KD-203A KD-202FGSM KD-202F XJ-2002DS-V XJ-2002DS XJ-2003A KD-202FB KD-202F-B KD-201A

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	2006-11-16

Official Correspondent

ZHAO JIAN YU

US Agent Details

Jianchun Huang Email: jvhuang001@gmail.com Phone: (720) 7711362

Related Public Records

Same Entity

SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI

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
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3011912849	BODYTRACE	San Jose, CA, US
3036999955	ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL	Largo, MD, US
3019575688	AKTIIA SA	Neuchatel, CH
3010222749	SEERS CO., LTD.	Pyeongtaek Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006543075. Last updated year: 2026. Please use registration number 3006543075 when referencing this establishment in official correspondence.