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Shanghai Caremate Medical Device Co. Ltd: FDA-registered device maker in Shanghai, China, 4 510(k) clearances

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

Shanghai Caremate Medical Device Co. Ltd is registered with the FDA (registration 3007699082) in Shanghai, China. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 19, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007699082
Address: Building 4, No. 281, Hong An Road Zhujing, Shanghai, China, 201503
Owner or operator: Shanghai Caremate Medical Device Co. Ltd (10029174)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
First device listed: April 13, 2009
Registered through: 2026
Brand names listed: ABN ANEROID SPHYGMOMANOMETER, Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer, Aneroid sphygmomanometer with stethoscope, Blood Pressure Cuff, Blood Pressure cuff, Penlight, Pressure Infusor, STETHOSCOPE and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Pressure Cuff	DXQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Manufacturer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Contract manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	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 19, 2021	K211084	Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope	DXQ	Substantially Equivalent	Shanghai Caremate Medical Device Co., Ltd.	accessdata.fda.gov
January 26, 2011	K102792	DISPOSABLE BLOOD PRESSURE CUF	DXQ	Substantially Equivalent	Caremate Medical Device Co., Ltd.	accessdata.fda.gov
April 9, 2009	K090014	CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE	DXQ	Substantially Equivalent	Caremate Medical Device Co., Ltd.	accessdata.fda.gov
August 16, 2001	K012444	ABN ANEROID SPHYGMOMANOMETER	DXQ	Substantially Equivalent	Pt. Sugih Instrumendo Abadi	accessdata.fda.gov

Compare with other makers

Updated October 19, 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.