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Anhui Tiankang Medical Technology Co., Ltd.: FDA-registered device maker in Tianchang Anhui, China, 10 510(k) clearances

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

Anhui Tiankang Medical Technology Co., Ltd. is registered with the FDA (registration 3007590959) in Tianchang Anhui, China. It lists 9 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 17, 2023. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3007590959
Address: No 228, WeiYi Road Economic Development Zone, Tianchang Anhui, China, 239300
Owner or operator: Anhui Tiankang Medical Technology Co., Ltd. (10042273)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: November 7, 2012
Registered through: 2026
Brand names listed: Bifurcated needle, Disposable infusion set with needle; Disposable infusion set without needle; Disposable infusion set with safety needle, Disposable syringe with permanently attached needle, safety syringe with permanently attached needle, Feeding tube, Fluid Dispensing Connector, I.V. administration set, IV Set with needle; IV set without needle; IV set with safety needle; IV set DEHP-Free, Infusion set with latex; infusion set latex free and more

Devices it lists

Device	Product code	Class	Role	Source
Allergen And Vaccine Delivery Needles	SCL	2	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer	accessdata.fda.gov
Saline, Vascular Access Flush	NGT	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	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
August 17, 2023	K222773	Feeding Tube	PIF	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
August 12, 2023	K230756	TK Pre-Filled Normal Saline Flush Syringe	NGT	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
December 6, 2022	K222385	Bifurcated Needle	SCL	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
July 14, 2022	K220204	Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle	FMF	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
September 11, 2020	K191639	TK Insulin Syringe with/without Saftey Retractable Device	MEG	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
August 26, 2020	K191640	TK Intravascular Administration Set	FPA	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
August 6, 2020	K191644	TK Safety Needle	FMI	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
January 6, 2020	K191642	TK Sterile Piston Syringe without Needle	FMF	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
December 19, 2019	K191643	TK Sterile Hypodermic Needle	FMI	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.	accessdata.fda.gov
May 12, 2014	K131531	TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE	MEG	Substantially Equivalent	Anhui Tiankang Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 17, 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.