Data / Medical devices / China / Changzhou DSB Medical Co., Ltd

Changzhou DSB Medical Co., Ltd: FDA-registered device maker in Changzhou City Jiangsu, China, 1 510(k) clearance

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

Changzhou DSB Medical Co., Ltd is registered with the FDA (registration 3008850249) in Changzhou City Jiangsu, China. It lists 16 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008850249
Address: No. 355 Longjin Road,, Changzhou Economic Development Zone Jiangsu Province, Changzhou City Jiangsu, China, 213025
Owner or operator: Changzhou DSB Medical Co., Ltd (10035099)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: February 3, 2011
Registered through: 2026
Brand names listed: Convenience Bag, CultureSafe, DISPOSABLE FACE MASK, DSB Urine Bag, DSB extension tubing irrigation system, DSB specimen container tube and cap, Disposable meidical protective mask, Disposable procedural Ear-loop Face Mask and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Contract manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Bag, Urine Collection, Newborn	FOC	2	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Contract manufacturer	accessdata.fda.gov
Collector, Urine, (And Accessories) For Indwelling Catheter	KNX	2	Manufacturer	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Contract manufacturer	accessdata.fda.gov
Cover, Barrier, Protective	MMP	2	Contract manufacturer	accessdata.fda.gov
Cover, Cast	KIA	1	Contract manufacturer	accessdata.fda.gov
Device, General Purpose, Microbiology, Diagnostic	LIB	1	Contract manufacturer	accessdata.fda.gov
Device, Incontinence, Urosheath Type, Non-Sterile	NNX	1	Manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Micro Pipette	JRC	1	Contract manufacturer	accessdata.fda.gov
System, Irrigation, Urological	LJH	2	Contract manufacturer	accessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	NNZ	1	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
July 15, 2021	K211042	Disposable Procedural Ear-loop Face Mask	FXX	Substantially Equivalent	Changzhou Dsb Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 15, 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.