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Ningbo Tianyi Medical Appliance CO., Ltd.: FDA-registered device maker in Ningbo Zhejiang, China, 1 510(k) clearance

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

Ningbo Tianyi Medical Appliance CO., Ltd. is registered with the FDA (registration 3006795797) in Ningbo Zhejiang, China. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006795797
Address: No.788,Mozhi North Rd Tourism Resort, Dongqian Lake, Ningbo Zhejiang, China, 315121
Owner or operator: Ningbo Tianyi Medical Appliance CO. Ltd. (10023011)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: May 4, 2009
Registered through: 2026
Brand names listed: ANTI-REFLUX VALVE, Bacterial/Viral Filter {BVF}, EnteralExtensionSets, INTRAVASCULAR ADMINISTRATION SET, Oral/Enteral Syringe, Polyurethane Feeding Tube, Silicone Feeding Tube, TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) and more

Devices it lists

Device	Product code	Class	Role	Source
Dispenser, Liquid Medication	KYX	1	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Enteral Syringes With Enteral Specific Connectors	PNR	2	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tube, Double Lumen For Intestinal Decompression And/Or Intubation	FEG	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tube, Feeding	FPD	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tube, Nasogastric	BSS	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Utensil, Eating	ILC	1	Contract manufacturer, Contract sterilizer	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
April 28, 2021	K210621	Oral/Enteral Syringe	PNR	Substantially Equivalent	Ningbo Tianyi Medical Appliance Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 28, 2021. 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.