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Shenzhen Caremed Medical Technology Co.,Ltd.: FDA-registered device maker in shenzhen Guangdong, China, 5 510(k) clearances

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

Shenzhen Caremed Medical Technology Co.,Ltd. is registered with the FDA (registration 3011713222) in shenzhen Guangdong, China. It lists 8 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 6, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011713222
Address: 3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road Gaofeng Community, Dalang office, Longhua District, Shenzhen, shenzhen Guangdong, China, 518109
Owner or operator: Shenzhen Caremed Medical Technology Co.,Ltd. (10049378)
Roles: Contract manufacturer, Manufacturer
First device listed: May 22, 2015
Registered through: 2026
Brand names listed: 2585P, 853030005, Blood Pressure cuffs, C103F-49R, C403-01, C403B-01X, C403B-117, C403B-49R and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Binder, Abdominal	FSD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Oximeter	DQA	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
December 6, 2019	K191279	Disposable SpO2 Sensor	DQA	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.	accessdata.fda.gov
September 6, 2019	K182751	Reusable Temperature Probe	FLL	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.	accessdata.fda.gov
December 17, 2018	K182433	Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff	DXQ	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.	accessdata.fda.gov
January 4, 2017	K153184	Caremed Reusable & Disposable SPO2 Sensors	DQA	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.	accessdata.fda.gov
October 24, 2016	K153188	Caremed patient cable and leadwires	DSA	Substantially Equivalent	Shenzhen Caremed Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 6, 2019. 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.