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Zhejiang Longterm Medical Technology Co., LTD: FDA-registered device maker in Huzhou City Zhejiang, China, 4 510(k) clearances

Name: Zhejiang Longterm Medical Technology Co., LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhejiang Longterm Medical Technology Co., LTD is registered with the FDA (registration 3009655869) in Huzhou City Zhejiang, China. It lists 26 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 31, 2022. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009655869
Address: ShuangShan Road 277, Fuxi Street, Deqing County, Huzhou City Zhejiang, China, 313200
Owner or operator: Zhejiang Longterm Medical Technology Co., LTD (10040883)
Roles: Contract manufacturer, Manufacturer
First device listed: May 29, 2012
Registered through: 2026
Brand names listed: ADHESIVE TAPE AND BANDAGE, Absorbent pad, Alginate Dressing, Anti-leakage strip, Board, Arm (With Cover), Sterile, Bouffant Cap, Chest Pillow, Drape Protector and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Hygiene	ILS	1	Manufacturer	accessdata.fda.gov
Bag, Drainage, With Adhesive, Ostomy	FON	1	Manufacturer	accessdata.fda.gov
Bandage, Liquid, Skin Protectant	NEC	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Board, Arm (With Cover), Sterile	BTX	1	Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Manufacturer	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	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	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2	Manufacturer	accessdata.fda.gov
Nursing Pad, Hydrogel	NTC	1	Manufacturer	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer	accessdata.fda.gov
Protector, Ostomy	EXE	1	Manufacturer	accessdata.fda.gov
Silicone Hydrogel For Scar Management	PFP	1	Manufacturer	accessdata.fda.gov
Strip, Adhesive, Closure, Skin	FPX	1	Manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	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
May 31, 2022	K211571	Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit	OMP	Substantially Equivalent	Zhejiang Longterm Medical Technology Co., Ltd.	accessdata.fda.gov
December 15, 2021	K202823	Innomed NPWT Silicone Foam Dressing	OMP	Substantially Equivalent	Zhejiang Longterm Medical Technology Co., Ltd.	accessdata.fda.gov
June 17, 2020	K192478	LT Antibacterial Alginate with Silver Dressing	FRO	Substantially Equivalent	Zhejiang Longterm Medical Technology Co., Ltd.	accessdata.fda.gov
May 23, 2019	K182458	Longterm NPWT Foam Dressing Kit	OMP	Substantially Equivalent	Zhejiang Longterm Medical Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 31, 2022. 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.