Data / Medical devices / China / Sunny Medical Device (shenzhen) Co., Ltd.

Sunny Medical Device (shenzhen) Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 6 510(k) clearances

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

Sunny Medical Device (shenzhen) Co., Ltd. is registered with the FDA (registration 3007361214) in Shenzhen Guangdong, China. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 16, 2020. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Sunny Medical Device (shenzhen) Co., Ltd.

FDA registration number: 3007361214
Address: 1/F, Zhongtianxin Building B Longgang District,Shenzhen,Guangdong, Shenzhen Guangdong, China, 518172
Owner or operator: Sunny Medical Device (Shenzhen) Co., Ltd. (10043316)
Roles: Contract manufacturer, Manufacturer
First device listed: February 5, 2013
Registered through: 2027
Brand names listed: AirTightTM Control Syringes, Sunmed, SunmedTM Control Syringes, SunmedTM High Pressure Line, SunmedTM Inflation Device, SunmedTM Manifold and Stopcocks, SunmedTM Protective face shield, SunmedTM guidewire torque device

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Manufacturer	accessdata.fda.gov
Trocar	DRC	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	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
March 16, 2020	K191827	Sunmed Disposable Angio-Closure Pads	DXC	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
November 10, 2016	K160190	Sunmed Control Syringes	DXT	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
October 13, 2016	K153685	Sunmed Haemostatic Valves	DQX	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
March 20, 2015	K140356	SUMMED HIGH PRESSURE LINE	DQO	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
December 12, 2014	K133795	SUMMED INFLATION DEVICE KIT	MAV	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov
May 11, 2012	K120119	SUNMED GUIDE WIRE	DQX	Substantially Equivalent	Sunny Medical Device (Shenzhen) Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 16, 2020. 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.