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Hantech Medical Device Co., Ltd.: FDA-registered device maker in Cixi Zhejiang, China, 5 510(k) clearances

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

Hantech Medical Device Co., Ltd. is registered with the FDA (registration 3015060216) in Cixi Zhejiang, China. It lists 18 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 27, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015060216
Address: No.288, Sanheng Road, Changhe Industrial Park,Cixi, 315326, Ningbo, P. R. China, Cixi Zhejiang, China, 315326
Owner or operator: Hantech Medical Device Co., Ltd. (10058745)
Roles: Contract manufacturer, Manufacturer
First device listed: August 3, 2020
Registered through: 2026
Brand names listed: Absorbent Paper Points, Amniotic Membrane Perforators, Arterial Blood Gas Samplers, Braun ThermoScan Lens Filters, Dental Foil, Disposable Insulin Pen Needle, Disposable Insulin Syringe, Disposable Medical Masks and more

Devices it lists

Device	Product code	Class	Role	Source
Amniotome	HGE	1	Manufacturer	accessdata.fda.gov
Arterial Blood Sampling Kit	CBT	1	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Contract manufacturer	accessdata.fda.gov
Clamp And Cutter, Umbilical	NBZ	2	Manufacturer	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Manufacturer	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Contract manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Contract manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Point, Paper, Endodontic	EKN	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Contract manufacturer	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
Tube Impression And Matrix	KCQ	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
September 27, 2023	K231363	Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)	NGT	Substantially Equivalent	Hantech Medical Device Co., Ltd.	accessdata.fda.gov
April 6, 2023	K222739	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Hantech Medical Device Co., Ltd.	accessdata.fda.gov
March 6, 2023	K222672	Disposable Insulin Syringe	FMF	Substantially Equivalent	Hantech Medical Device Co., Ltd.	accessdata.fda.gov
September 1, 2022	K221038	Disposable Medical Masks	FXX	Substantially Equivalent	Hantech Medical Device Co., Ltd.	accessdata.fda.gov
August 23, 2022	K220603	Disposable Medical Safety Hypodermic Needle	FMI	Substantially Equivalent	Hantech Medical Device Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 27, 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.