Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011193403

FEI Number

3011193403

Entity Name

YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD

City/State/Country

Yangzhou Jiangsu, CN

Establishment Address

Beizhou Road, Lidian Town, Guangling District, Yangzhou Jiangsu 225106, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yangzhou Fartley Medical Instrument Technology Co., Ltd (Owner Number: 10047116)

Owner / Operator Contact Address

Beizhou Road, Lidian Town, Guangling District, Yangzhou, CN-JS 225106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Transport Tray Instrument Covers Disposable Endoscope Injection Needle Bedside Cleaning Sponge with enzymatic cleaner and tray Bedside Cleaning Sponge with 1000ml tray Heliclip Disposable Hemoclip Disposable Bite Block Transport Pad Disposable Endoscopy Adapter Set CO2 Adapter Disposable Polypectomy Hot Snare Disposable Polypectomy Hybrid Snare Suction Tube Disposable Grasping Forceps Caesar Alligator RAT TOOTH GRASPING FORCEPS Harness Disposable Stone Retrieval Basket Disposable Endoscope Cleaning Brushes Disposable Cleaning Valve Disposable Distal Tip Protector Disposable Transport bag Single-Use ErgoGrip Knob Extender Single Use Cleaning Brush Single-use Combination Cleaning Brush Single Use Angulation Knob Extender for Olympus 160/180/190 series endoscopes Disposable Biopsy Forceps,Non-Electric Endoscopy Procedure Kit Medical Lubricant Jelly Disposable Polypectomy Cold Snare,Non-Electrical Disposable Retrieval Snare Net Cold AcuSnare Polypectomy Snare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2022-09-02
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2022-09-02
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2023-10-12
PKL	Hemostatic Metal Clip For The Gi Tract	Gastroenterology, Urology	Class 2	876.4400	2023-08-08
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2014-07-02
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-05-06
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2022-09-02
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2022-09-02
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2022-09-02
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-08-20
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2023-10-12
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2022-01-03
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2025-08-20
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2023-07-27
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2026-02-09
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2014-07-02
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2018-06-03
NWU	Endoscope Introducer Kit	Gastroenterology, Urology	Class 2	876.1500	2023-10-12
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2022-09-02
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2022-01-03

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
3035786158	Yangzhou Fartley Medical Instrument Technology Co., Ltd	Yangzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K200745	United States Endoscopy Group, Inc.	Lariat, Hot/Cold Snare	2020-04-21
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

Similar Registrations

Registration Number	Establishment Name	Location
3018313280	BAGS AND GLOVES CO., LTD.	BANGKOKNOI Krung Thep Maha Nakhon, TH
9611102	RICHARD WOLF GMBH	KNITTLINGEN Baden-Wurttemberg, DE
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
9610595	AIZU OLYMPUS CO., LTD.	AIZUWAKAMATSU-SHI Fukushima, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011193403. Last updated year: 2026. Please use registration number 3011193403 when referencing this establishment in official correspondence.