Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035786158

FEI Number

3035786158

Entity Name

Yangzhou Fartley Medical Instrument Technology Co., Ltd

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

No. 7 Youkang Road, Touqiao Town, Guangling District, Yangzhou Jiangsu 225000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yangzhou Fartley Medical Instrument Technology Co., Ltd (Owner Number: 10092360)

Owner / Operator Contact Address

No. 7 Youkang Road, Touqiao Town, Guangling District, Yangzhou, CN-JS 225000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-Woven Gauze Suction Tube Bedside Cleaning Sponge with enzymatic cleaner and tray Bedside Cleaning Sponge with 1000 ml Tray Disposable Bite Block SafeSnap Polyp Trap/E-tech Harness

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-12-28
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2024-12-28
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2024-12-28
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2024-12-28
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2025-02-10
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2024-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Yangzhou Fartley Medical Instrument Technology Co., Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011193403	YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD	Yangzhou Jiangsu, CN

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035786158. Last updated year: 2026. Please use registration number 3035786158 when referencing this establishment in official correspondence.