Data / Medical devices / China / Voncare Medical Device Co Ltd

Voncare Medical Device Co Ltd: FDA-registered device maker in Huizhou Guangdong, China, 1 510(k) clearance

Name: Voncare Medical Device Co Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Voncare Medical Device Co Ltd is registered with the FDA (registration 3011307234) in Huizhou Guangdong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 6, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011307234
Address: 2nd South Road, District 8, Shiwan Town, Huizhou Guangdong, China, 516127
Owner or operator: VONCARE MEDICAL DEVICE CO LTD (10047792)
Roles: Manufacturer
First device listed: November 2, 2014
Registered through: 2026
Brand names listed: Adhesive Electrode, Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231550NS, BB231560NS, BB234050NS, BB234060NS, BB231550FL, BB234050FL, Disposable Cardiology Electrodes BBCARE-Ag/Agcl: BB231560FL, BB234060FL,BB234034NS, BB234035FL, Disposable Cardiology electrodes BBCARE-Ag: BB231550NV, BB234050NV, BB201550NV, BB204050NV, BB301550NR, BB304050NR, Disposable Cardiology electrodes BBCARE-Ag: BB231560NV, BB234060NV, BB201560NV, BB204060NV, BB301560NR, BB234035NV, Disposable Cardiology electrodes BBCARE-Ag:BB204035NV, BB304035NR, BB304050NG, BB304035NG, NG-NO GEL, Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT: BBTR231550, BBTR234050, BBTR321550, BBTR324050, BBTR231560, Disposable Cardiology electrodes BBCARE-RADIOTRANSLUSCENT:BBTR234060, BBTR321560, BBTR324060 and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 6, 2021	K212191	Adhesive Electrodes	GXY	Substantially Equivalent	Voncare Medical Device Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 6, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.