Data / Medical devices / China / HongYu BioTech (ShenZhen) Co., Ltd

HongYu BioTech (ShenZhen) Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Name: HongYu BioTech (ShenZhen) Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HongYu BioTech (ShenZhen) Co., Ltd is registered with the FDA (registration 3017107376) in Shenzhen Guangdong, China. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3017107376
Address: NO.806, Finance Center, NO.22 Taizi Road, Shuiwan Community, Zhaoshang Street, Shenzhen Guangdong, China, 518067
Owner or operator: HongYu BioTech (ShenZhen) Co., Ltd (10079513)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 10, 2020
Registered through: 2026
Brand names listed: Alcohol Prep Pad/Cleansing Pads, Cane, Cast Cover, Collagen Dressing, Disinfectant, Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne Patch,, Folding Walker, Hydrocolloid Gel Bandages and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Hygiene	ILS	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Cover, Cast	KIA	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Dilator, Nasal	LWF	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Contract manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Strip, Adhesive, Closure, Skin	FPX	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Tips And Pads, Cane, Crutch And Walker	INP	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Exporter to the US, 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
June 3, 2026	K253974	Roosin Collagen Dressing	KGN	Substantially Equivalent	Roosin Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 3, 2026. 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.