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Shanghai Kindly Enterprise Development Group Co., Ltd.: FDA-registered device maker in JIADING Shanghai, China, 4 510(k) clearances

Name: Shanghai Kindly Enterprise Development Group Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shanghai Kindly Enterprise Development Group Co., Ltd. is registered with the FDA (registration 3005405146) in JIADING Shanghai, China. It lists 11 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 12, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005405146
Address: No. 658 Gaochao Road, JIADING Shanghai, China, 201803
Owner or operator: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. (9078499)
Roles: Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Specification developer
First device listed: October 13, 2005
Registered through: 2027
Brand names listed: Blood Collection Device, Blood Collection Tube Holder, Blunt Tip Aspirating Neelde, Bulb Syringe, Disposable Needles, Disposable Syringe without needle, DropSafe Insulin Safety Syringe, EXEL 1ml Delivery Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Contract manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Low Dead Space Piston Syringe	QNQ	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Contract manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Ophthalmic Syringe	QLY	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	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
December 12, 2023	K233037	Sterile Hypodermic Needles for Single Use	FMI	Substantially Equivalent	Zhejiang Kindly Medical Device Co., Ltd.	accessdata.fda.gov
February 16, 2023	K223327	Sterile Aesthetic Cannula and Hypodermic Needle	FMI	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd.	accessdata.fda.gov
February 9, 2023	K223678	Sterile Syringes for Single Use	FMF	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd.	accessdata.fda.gov
December 14, 2011	K112057	KDL SYRINGES AND NEEDLE	FMF	Substantially Equivalent	Shanghai Kindly Enterprise Dev. Group Co.,	accessdata.fda.gov

Compare with other makers

Updated December 12, 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.