Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010880718

FEI Number

3010880718

Entity Name

GLOBALCARE MEDICAL TECHNOLOGY CO., LTD

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, Zhongshan City Guangdong 528415, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Globalcare Medical Technology Co., Ltd (Owner Number: 10046812)

Owner / Operator Contact Address

7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, Zhongshan City, CN-GD 528415, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEB 200

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	2023-06-14
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2026-05-12
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-05-12
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-11-18
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2025-11-18
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-04-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-05-16
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2018-07-02
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-01-06
OCR	Lung Sound Monitor	Cardiovascular	Class 2	870.1875	2023-06-14
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2020-09-02
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-10-28

Official Correspondent

Cherry Feng

US Agent Details

Terrence O'Brien Business: Project Marketing Email: 1968sfp@gmail.com Phone: (919) 6231053

Related Public Records

Same Entity

Globalcare Medical Technology 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
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3006543075	SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI	SHANGHAI, CN
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010880718. Last updated year: 2026. Please use registration number 3010880718 when referencing this establishment in official correspondence.