Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006795797

FEI Number

3006795797

Entity Name

Ningbo Tianyi Medical Appliance CO., Ltd.

City/State/Country

Ningbo Zhejiang, CN

Establishment Address

No.788,Mozhi North Rd, Tourism Resort, Dongqian Lake, Ningbo Zhejiang 315121, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ningbo Tianyi Medical Appliance CO. Ltd. (Owner Number: 10023011)

Owner / Operator Contact Address

No.788,Mozhi North Rd, Tourism Resort, Dongqian Lake, Ningbo, CN-ZJ 315121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210621

PMA Number

N/A

All Registered Proprietary Names

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) Bacterial/Viral Filter {BVF} Vitalograph Model 2820 ANTI-REFLUX VALVE Oral/Enteral Syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2025-11-18
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2012-11-13
FPD	Tube, Feeding	Gastroenterology, Urology	Class 2	876.5980	2009-05-04
BSS	Tube, Nasogastric	Gastroenterology, Urology	Class 2	876.5980	2009-05-04
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2017-10-27
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2012-11-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2009-05-04
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2019-08-28
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	Class 2	876.5980	2018-08-21
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2024-02-23

Official Correspondent

Bin Wu

US Agent Details

James H. Liao Business: APAX International, Inc. Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

Ningbo Tianyi Medical Appliance CO. Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006795797. Last updated year: 2026. Please use registration number 3006795797 when referencing this establishment in official correspondence.