Data / Medical devices / China / Zhejiang Kindly Medical Devices Co., Ltd

Zhejiang Kindly Medical Devices Co., Ltd: FDA-registered device maker in WENZHOU Zhejiang, China, 6 510(k) clearances

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

Zhejiang Kindly Medical Devices Co., Ltd is registered with the FDA (registration 9615588) in WENZHOU Zhejiang, China. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 12, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9615588
FEI number: 3003560965
Address: No.758, 5th Binhai Road Binhai Industrial Park, Longwan District, WENZHOU Zhejiang, China, 325025
Owner or operator: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD (9036461)
Roles: Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: February 5, 2008
Registered through: 2027
Brand names listed: Anesthesia needles, BCS Safety Holder, Blood Collecting Needle, Blood Collecting Needle with Holder, Blood Collection Adapter, Blood Collection Device, Blood Collection Holder, Blood Collection Luer Adapter and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Catheter	GCE	1	Manufacturer	accessdata.fda.gov
Adaptor, Holder, Syringe	IQG	1	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Low Dead Space Needle, Single Lumen, Hypodermic	QNS	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Low Dead Space Piston Syringe	QNQ	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Ophthalmic Needle	QYM	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Ophthalmic Syringe	QLY	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Parenteral Administration Kit	POR	2	Repackager or relabeler	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	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Contract manufacturer, Contract sterilizer, 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
December 16, 2022	K223334	Sterile Hypodermic Needles for Single Use	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
October 14, 2022	K213183	Safety Insulin Pen Needles	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
August 28, 2018	K181069	Disposable Insulin Pen Needle	FMI	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
June 4, 2018	K172763	Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder	JKA	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov
January 5, 2018	K171518	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles	BSP	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 24, 2021	88757	Class II	Terminated	McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS	Potential for difficulty in safety mechanism activation.	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.