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BQ Plus Medical Co.,ltd: FDA-registered device maker in SONGJIANG Shanghai, China, 3 510(k) clearances

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

BQ Plus Medical Co.,ltd is registered with the FDA (registration 3013023255) in SONGJIANG Shanghai, China. It lists 13 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.

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FDA registration number: 3013023255
Address: No.18, Cheye RD, Chedun Town, SONGJIANG Shanghai, China, 201611
Owner or operator: BQ PLUS MEDICAL CO.,LTD (10054083)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: December 13, 2017
Registered through: 2026
Brand names listed: Disposable Cytology Brush (AF series), Disposable Endoscope Valves Set (AF series), Disposable Hemoclip (AF series), Disposable Injection Needle AF series, Endoscopic Distal Attachment (AF-D series), KMC Kyphoplasty System, Ureteral Stents (AF-D series), anesthesia face mask

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Contract sterilizer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Contract sterilizer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Contract sterilizer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Contract sterilizer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Contract sterilizer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Contract sterilizer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Contract sterilizer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Contract sterilizer	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Contract sterilizer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract 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
August 22, 2024	K242126	I.V. Administration Set	FPA	Substantially Equivalent	Bq Plus Medical Co., Ltd.	accessdata.fda.gov
May 18, 2023	K223645	I.V. Administration Set, I.V. Extension Set	FPA	Substantially Equivalent	Bq Plus Medical Co., Ltd.	accessdata.fda.gov
August 14, 2021	K210381	I.V. Administration Set	FPA	Substantially Equivalent	Bq 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.