Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017942784

FEI Number

3017942784

Entity Name

SHANDONG CORECARE TECHNOLOGY LIMITED

City/State/Country

Jinan Shandong, CN

Establishment Address

Suite 801-2, Incubator Phase I, Innovation Valley, Jinan High-Tech Industrial Development Zone, Jinan Shandong 250300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong CoreCare Technology Limited (Owner Number: 10079785)

Owner / Operator Contact Address

Suite 801-2, Incubator Phase I, Innovation Valley, Jinan High-Tech Industrial Development Zone, Jinan, CN-SD 250307, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222842

PMA Number

N/A

All Registered Proprietary Names

CoreCare Cardiac Monitor eCordum Cardiac Monitor V-Patch Cardiac Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2022-11-06

Official Correspondent

Cao Cheng

US Agent Details

Yiqun Zhou Email: zhouyiqun2002@gmail.com Phone: (650) 8684225

Related Public Records

Same Entity

Shandong CoreCare Technology Limited

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
K820986	Dart Medical Equipment	EKG MONITORS, VARIOUS MODELS	1982-04-29
K910450	Medtech Industries, Inc.	CARD GUARD-3000 ECG TELEPHONE ADAPTER	1991-05-07
K761318	Cambridge Instruments, Inc.	3038 OPTION B-COMPUT. TRANS. TERMINAL	1977-01-06
K972649	Reynolds Medical , Ltd.	CARDIOCALL CARDIAC EVENT RECORDER	1997-12-04
K033410	Remote Diagnostic Technologies , Ltd.	TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002	2004-03-05

Similar Registrations

Registration Number	Establishment Name	Location
3013250653	MASIMO CORPORATION	Irvine, CA, US
3015976873	QOMPIUM NV	Hasselt Limburg, BE
3010742884	Otsuka America Pharmaceutical, Inc	Hayward, CA, US
3042928308	TAIWAN SCIENTIFIC CORPORATION	New Taipei, TW
3017884848	KITRON TECHNOLOGIES INC.	Windber, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017942784. Last updated year: 2026. Please use registration number 3017942784 when referencing this establishment in official correspondence.