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Linc Medipharm Limited: FDA-registered device maker in Wuxi Jiangsu, China, 11 510(k) clearances

Name: Linc Medipharm Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Linc Medipharm Limited is registered with the FDA (registration 3039435934) in Wuxi Jiangsu, China. It lists 6 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 7, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3039435934
Address: Unit F01, 8/F, Office Tower 2, Center 66, 139 Renmin Zhong Road, Liangxi, Wuxi Jiangsu, China, 214001
Owner or operator: Linc Medipharm Limited (10096300)
Roles: Exporter to the US
First device listed: August 26, 2026
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Exporter to the US	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Exporter to the US	accessdata.fda.gov
Syringe, Antistick	MEG	2	Exporter to the US	accessdata.fda.gov
Syringe, Piston	FMF	2	Exporter to the US	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Exporter to the US	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 7, 2024	K232781	Safety Sliding Blood Collection Set	JKA	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd	accessdata.fda.gov
November 30, 2023	K230061	Insulin Syringe	FMF	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
September 20, 2023	K230043	Insulin Pen Needle	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
November 17, 2022	K221178	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
November 15, 2022	K222055	Disposable Sterile Lancet	FMK	Substantially Equivalent	Tianjin Rilifine Medical Device Co., Ltd.	accessdata.fda.gov
October 3, 2022	K222376	Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)	FMK	Substantially Equivalent	Shandong Lianfa Medical Plastic Products Co. , Ltd.	accessdata.fda.gov
September 30, 2022	K222090	Safety Lancet	FMK	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.	accessdata.fda.gov
April 12, 2022	K214075	Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)	FMI	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	accessdata.fda.gov
July 2, 2021	K202570	Insulin Syringe, Insulin Syringe with Safety Retractable	MEG	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.	accessdata.fda.gov
December 29, 2016	K162180	Disposable Insulin Syringe	FMF	Substantially Equivalent	Berpu Medical Technology Co., Ltd.	accessdata.fda.gov
February 25, 2014	K133059	INSULIN PEN NEEDLE	FMI	Substantially Equivalent	Wenzhou Beipu Science & Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 7, 2024. 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.