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Shandong Caremed Medical Products Co.,ltd.: FDA-registered device maker in Heze Shandong, China, 6 510(k) clearances

Name: Shandong Caremed Medical Products Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shandong Caremed Medical Products Co.,ltd. is registered with the FDA (registration 3012461127) in Heze Shandong, China. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 25, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012461127
Address: YanTai Industrial Park, Ding Tao Country East of Zhanqian Road, Heze Shandong, China, 274100
Owner or operator: Shandong Caremed Medical Products Co.,Ltd. (10050312)
Roles: Exporter to the US, Manufacturer
First device listed: November 2, 2016
Registered through: 2026
Brand names listed: Insulin Syringe, piston, NEEDLE, DENTAL, Needle, hypodermic, single lumen, Set, administration, intravascular, Syringe, irrigating (dental), Syringe, piston

Devices it lists

Device	Product code	Class	Role	Source
Needle, Dental	DZM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Dental)	EIB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US, 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 25, 2016	K152808	U&U Insulin Syringe with/without Safety Retractable Device	MEG	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
March 7, 2016	K152824	MEDT PEN NEEDLE	FMI	Substantially Equivalent	Shandong Caremed Medical Products Co., Ltd.	accessdata.fda.gov
September 24, 2015	K151151	U & U Intravascular Administration Set	FPA	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
August 11, 2015	K142765	TM SAFETY NEEDLE	FMI	Substantially Equivalent	Thinkmed Medical Technology Co., Ltd.	accessdata.fda.gov
February 27, 2014	K132553	U&U STERILE PISTON SYRINGE WITHOUT NEEDLE	FMF	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov
November 13, 2013	K132552	U&U STERILE HYPODERMIC NEEDLE	FMI	Substantially Equivalent	U&U Medical Technology Co, Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 25, 2016. 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.