Data / Medical devices / China / Zhende Medical Co., Ltd.

Zhende Medical Co., Ltd.: FDA-registered device maker in SHAOXING Zhejiang, China, 3 510(k) clearances

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

Zhende Medical Co., Ltd. is registered with the FDA (registration 3003348807) in SHAOXING Zhejiang, China. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 28, 2021. 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.

Get makers like this one Watch Zhende Medical Co., Ltd.

FDA registration number: 3003348807
Address: Gaobu Town, SHAOXING Zhejiang, China, 312035
Owner or operator: Zhende Medical Co., Ltd (9050974)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: April 29, 2002
Registered through: 2026
Brand names listed: Isosafe Earloop Procedure Mask(Blue,Yellow), Ostomy ring

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Elastic	FQM	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cement, Stomal Appliance, Ostomy	EZR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drape, Surgical, Exempt	PUI	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US	accessdata.fda.gov
Gown, Surgical	FYA	2	Exporter to the US	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US	accessdata.fda.gov
Ostomy Care Kit	PQE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Protector, Ostomy	EXE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Contract manufacturer, 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
April 28, 2021	K210020	Medical Mask	FXX	Substantially Equivalent	Zhende Medical Co., Ltd.	accessdata.fda.gov
December 3, 2020	K201729	Medical Mask	FXX	Substantially Equivalent	Zhende Medical Co., Ltd.	accessdata.fda.gov
April 30, 2020	K192290	50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown	FYA	Substantially Equivalent	Xuchang Zhengde Environstar Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 28, 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.