Data / Medical devices / China / Jiangsu Newvalue Medical Products Co., Ltd.

Jiangsu Newvalue Medical Products Co., Ltd.: FDA-registered device maker in Taizhou Jiangsu, China, 2 510(k) clearances

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

Jiangsu Newvalue Medical Products Co., Ltd. is registered with the FDA (registration 3027517726) in Taizhou Jiangsu, China. It lists 12 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3027517726
Address: No.22 Zelan Road, China Medical City, Taizhou Jiangsu, China, 225300
Owner or operator: Jiangsu NewValue Medical Products Co., Ltd. (10048334)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: December 30, 2014
Registered through: 2026
Brand names listed: ACNE PIMPLE PATCHES, Curaplex IV Guard IV Dressing Breathable, Curaplex Select Transparent Dressing, Disposable Surgical Face Mask, Dressing, wound, hydrophilic (Alginate dressing), Dressing, wound, occlusive (Hydrocolloid dressing, foam dressing, silicone adhesive dressing), Hemostatic Dressing, Hydrocolloid Adhesive Bandages and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Intravascular Catheter Securement	KMK	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Exporter to the US, Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Contract manufacturer, Exporter to the US, 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
Wound Dressing With Animal-Derived Material(S)	KGN	U	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
September 1, 2023	K213413	Hemostatic Dressing	QSY	Substantially Equivalent	Jiangsu Newvalue Medical Products Co., Ltd.	accessdata.fda.gov
January 6, 2021	K202491	Disposable Surgical Face Mask	FXX	Substantially Equivalent	Jiangsu Newvalue Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 1, 2023. 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.