Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011307234

FEI Number

3011307234

Entity Name

VONCARE MEDICAL DEVICE CO LTD

City/State/Country

Huizhou Guangdong, CN

Establishment Address

2nd South Road, District 8, Shiwan Town, Huizhou Guangdong 516127, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VONCARE MEDICAL DEVICE CO LTD (Owner Number: 10047792)

Owner / Operator Contact Address

2nd South Road, District 8, Shiwan Town, Huizhou, CN-GD 516127, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231550NS, BB231560NS, BB234050NS, BB234060NS, BB231550FL, BB234050FL Disposable Cardiology electrodes BBCARE-Ag: BB231560NV, BB234060NV, BB201560NV, BB204060NV, BB301560NR, BB234035NV Disposable Cardiology electrodes BBCARE-Ag: BB231550NV, BB234050NV, BB201550NV, BB204050NV, BB301550NR, BB304050NR Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT: BBTR231550, BBTR234050, BBTR321550, BBTR324050, BBTR231560 Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT:BBTR234060, BBTR321560, BBTR324060 Disposable Cardiology electrodes BBCARE-Ag:BB204035NV, BB304035NR, BB304050NG, BB304035NG, NG-NO GEL Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231560FL, BB234060FL,BB234034NS, BB234035FL Disposable Snap Cardiology Electrodes: T716,T707,T707L,T706M,T709,T709RT Adhesive Electrode Face Mask VC-001-KN90; VC-001-KN95 Disposable Isolation Cloth VC-002-DC-011, VC-002-DC-012, VC-002-DC-013, VC-002-DC-014, VC-002-DC-015 Isolation Mask VC-001-KN90; VC-001-KN95 Disposable Isolation Cloth VC-002-DC-016, VC-002-DC-017, VC-002-DC-018, VC-002-DC-019, VC-002-DC-020 Disposable Isolation Cloth VC-002-DC-006, VC-002-DC-007, VC-002-DC-008, VC-002-DC-009, VC-002-DC-010 Disposable Isolation Cloth VC-002-DC-001, VC-002-DC-002, VC-002-DC-003, VC-002-DC-004, VC-002-DC-005

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2014-11-02
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-12-27
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-24

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

VONCARE MEDICAL DEVICE 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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03

Similar Registrations

Registration Number	Establishment Name	Location
3013522941	JOHNSON MEDTECH LLC	Vandalia, OH, US
3013873578	SHANGHAI YUECHEN MEDICAL SUPPLY CO..LTD.	Shanghai, CN
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3017425211	LOHMANN PRECISION DIE CUTTING, LLC	Orange, VA, US
3008773647	CARDIONET, LLC	Phoenix, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011307234. Last updated year: 2026. Please use registration number 3011307234 when referencing this establishment in official correspondence.