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BQ Plus Medical Co., Ltd.: FDA-registered device maker in Huai An City Jiangsu, China, 3 510(k) clearances

BQ Plus Medical Co., Ltd. is registered with the FDA (registration 3036978618) in Huai An City Jiangsu, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 22, 2024. Registered through 2026. FDA data exported November 2, 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.

FDA registration number
3036978618
Address
No. 12, Gaogang New Zone, Huaigao Town, Huaiyin district, Huai An City Jiangsu, China, 223300
Owner or operator
BQ Plus Medical Co., Ltd. (10092734)
Roles
Contract manufacturer, Manufacturer
First device listed
February 12, 2025
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Set, Administration, IntravascularFPA2Contract manufacturer, Manufactureraccessdata.fda.gov
Syringe, PistonFMF2Contract manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 22, 2024K242126I.V. Administration SetFPASubstantially EquivalentBq Plus Medical Co., Ltd.accessdata.fda.gov
May 18, 2023K223645I.V. Administration Set, I.V. Extension SetFPASubstantially EquivalentBq Plus Medical Co., Ltd.accessdata.fda.gov
August 14, 2021K210381I.V. Administration SetFPASubstantially EquivalentBq Plus Medical Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 22, 2024. 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.