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Ningbo Medsun Medical Co., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 7 510(k) clearances

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

Ningbo Medsun Medical Co., Ltd. is registered with the FDA (registration 3009578786) in Ningbo Zhejiang, China. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 18, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009578786
Address: No. 298 Huangjipu Road, Jiangbei, Ningbo Zhejiang, China, 315031
Owner or operator: Ningbo Medsun Medical Co., Ltd. (10042392)
Roles: Contract manufacturer, Manufacturer
First device listed: November 22, 2012
Registered through: 2027
Brand names listed: Acti-Lance baby, Disposable Surgical Scalpel, GLUCO-CARE Pen Needles, Lancet, Lancing Device, MireMed Pen Needles, One-Care Safety Pen Needle, Safety Heel Lancet, Safety Lancet and more

Devices it lists

Device	Product code	Class	Role	Source
Blade, Scalpel	GES	1	Contract manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Contract manufacturer	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	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
March 18, 2026	K253622	Safety Pen Needle	FMI	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
February 20, 2026	K253605	Safety Heel Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
October 30, 2024	K242627	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
August 28, 2024	K242316	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
January 4, 2024	K232330	Lancing System	QRK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
November 17, 2022	K221178	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
September 30, 2022	K222090	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 18, 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.