Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Manufacturer and brand owner in Yangzhou, Jiangsu, China. 24 device types, 32 products catalogued, 8 clearances.

Registry build 21.09.26

Yangzhou Fartley Medical Instrument Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Snare, Flexible, Lubricant, Patient and 22 other device types. 32 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2014.

24device types registered with the FDA
32products catalogued under its own name
8510(k) clearances

Registration

FDA registration record for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Registered name YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD
Status Registered
Registration expires 2026
Registration number 3011193403
FEI number 3011193403
DUNS 544375774
Establishment type Contract manufacturer, Specification developer, Manufacturer, Exporter

Location

Address of Yangzhou Fartley Medical Instrument Technology Co., Ltd.
City Yangzhou
Province Jiangsu
Address Beizhou Road, Lidian Town, Guangling District
Postal code 225106
Country China

What It Makes

Device types Yangzhou Fartley Medical Instrument Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessories, Cleaning Brushes, For Endoscope Class 1 Single-use Combination Cleaning Brush, Disposable Transport Bag, Single Use Cleaning Brush, Single Use Angulation Knob Extender for Olympus 160/180/190 series endoscopes, Disposable Distal Tip Protector, Disposable Endoscope Cleaning Brushes and 2 more 2014 43
Adaptor, Bulbs, Miscellaneous, For Endoscope Class 1 Instrument Covers, Disposable Transport Tray 2022 6
Bedding, Disposable, Medical Class 1 Transport Pad 2024 308
Bottle, Collection, Vacuum Class 2 SafeSnap Polyp Trap/E-tech, Polyp Trap,Non-sterile 2021 88
Cleaner, Ultrasonic, Medical Instrument Class 1 Bedside Cleaning Sponge with 1000 ml Tray, Bedside Cleaning Sponge with enzymatic cleaner and tray, Bedside Cleaning Sponge with 1000ml tray 2023 48
Colonoscope And Accessories, Flexible/Rigid Class 2 Disposable Endoscopic Distal Attachments 2026 9
Dislodger, Stone, Basket, Ureteral, Metal Class 2 Disposable Stone Retrieval Basket 2026 21
Endoscope Channel Accessory Class 2 Disposable Endoscopy Adapter Set 2022 21
Endoscope Introducer Kit Class 2 Endoscopy Procedure Kit 2023 2
Endoscopic Bite Block Class 1 Disposable Bite Block 2014 44
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Class 2 Disposable Grasping Forceps, Caesar Alligator RAT TOOTH GRASPING FORCEPS 2022 21
Endoscopic Guidewire, Gastroenterology-Urology Class 2 Disposable Guide Wire 2026 21
Endoscopic Injection Needle, Gastroenterology-Urology Class 2 Disposable Endoscope Injection Needle 2022 23
Endoscopic Irrigation/Suction System Class 2 Clean Connecting Tube 2023 10
Forceps, Biopsy, Non-Electric Class 1 Disposable Biopsy Forceps,Non-Electric 2018 44
Gastroscope And Accessories, Flexible/Rigid Class 2 Disposable Endoscopic Distal Attachments 2026 9
Gauze / Sponge,Nonresorbable For External Use Class 1 Non-Woven Gauze 2023 266
Hemostatic Metal Clip For The Gi Tract Class 2 Disposable Hemoclip, Heliclip 2023 17
Holder, Camera, Surgical Class 1 Harness 2023 1
Lubricant, Patient Class 1 Medical Lubricant Jelly 2022 33
Snare, Flexible Class 2 SmartSnare EMR Hexagonal Snare, Disposable Polypectomy Hot Snare, Disposable Polypectomy Hybrid Snare 2021 7
Snare, Non-Electrical Class 1 Disposable Retrieval Snare Net, Disposable Polypectomy Cold Snare,Non-Electrical, Cold AcuSnare Polypectomy Snare 2022 19
Tube, Aspirating, Flexible, Connecting Class 2 Suction Tube 2023 51
Tubing/Tubing With Filter, Insufflation, Laparoscopic Class 1 CO2 Adapter 2022 12

Own-Brand Listings

Clearances

510(k) clearances naming Yangzhou Fartley Medical Instrument Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K260423 2026-05-28 FDF Traditional This company
K250732 2025-06-20 ODC Traditional This company
K230004 2023-07-31 PKL Traditional This company
K222980 2022-11-21 ODC Traditional This company
K220785 2022-09-27 OCX Traditional This company
K220292 2022-08-19 FBK Traditional This company
K220790 2022-06-27 FDI Traditional This company
K220210 2022-06-17 ODC Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Yangzhou Fartley Medical Instrument Technology Co., Ltd.
Founded 2013
Employees 350+
Factory area 7000 square meters
Main products ESD devices, ERCP devices, Gastrointestinal endoscopic treatment products, Urology products
Certifications NMPA, CE, MDSAP, KFDA, FDA
Export markets 60+ countries worldwide

Nearby Manufacturers

Other registered manufacturers in the same city
Manufacturer Device types
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Yangzhou Sensport Healthcare Supplies Co., Ltd. 27
Jiangsu Keling Medical Appliances Co., Ltd. 23
K-MED Co., Ltd. 20
Jiangsu Juneng Sports Goods Technology Co., Ltd. 18
Jiangsu Rongye Technology Co., Ltd. 16
Yangzhou Juli Sports Articles Co., Ltd. 16
Yangzhou Qionghua Sports Goods Co., Ltd. 15
Yangzhou Feiyali Sporting Goods Co., Ltd. 15
DayOn Daily Chemical Co., Ltd. 12
Yangzhou Haiwang Toothbrush Factory 12
Cohesion Health International Co., Ltd. 12
Yangzhou Medline Industry Co., Ltd. 11
Yangzhou Weideli Trading Co., Ltd. 10
Jiangsu Kangbao Medical Equipment Co., Ltd. 10
Yangzhou Zhilin Sports Items Co., Ltd. 10
Perfect Group Corp. Ltd. 9
Yangzhou Royal Home Products Manufacture Co., Ltd. 9
NEW Phenix Home Products Manufactory Co., Ltd. 9
Yangzhou Aolikes Sports Goods Co., Ltd. 8
Yangzhou Yichuan Plastic Technology Co., Ltd. 8
Jiangsu Yulong Medical Technology Co., Ltd. 8
Pesitro Healthcare Products Co., Ltd. 7
Yangzhou Qiangjing Sports Products Co., Ltd. 7
Yangzhou Jindu Sporting Goods Co., Ltd. 7
Jiangsu Sanxiao Group Co., Ltd. 7
Yangzhou Star Oral Care Product Co., Ltd. 7
Yangzhou Xintaiyang Plastic Daily Chemical Co., Ltd. 7
Yangzhou Xinhua Brushes Co., Ltd. 6
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LMZ 3
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Jiangsu Xingsheng Brush Co., Ltd. 3
Yangzhou Life Time Household Commodity Co., Ltd. 3
Jiangsu Pure Oral Care Products Co., Ltd. 3
Yangzhou Costco Daily USE Co., Ltd. 3
J-Energy Daily Care Products Co., Ltd. 2
Jiangsu Changfeng Medical Industry Co., Ltd. 2
Jiangsu Hope Biomedical Science&Technology Co., Ltd. 2
Yangzhou Chuangyou Science & Technology Development Co., Ltd. 2
Sainty International Group 1
Yangzhou Hengshengrui Rubber & Plastic Co., Ltd. 1
Yangzhou Huayin Tourist Daily Necessities Co., Ltd. 1
Qijin Amenities Co., Ltd. 1
Yangzhou Yangchen Daily Expenses Factory 1
Yangzhou City Xinhua Travel Products Factory 1
Yangzhou Xianfeng Tourists Factory Corporation 1
Colgate Sanxiao Co., Ltd. 1
AID United(Yangzhou) Medical Devices Co., Ltd. 1
Yangzhou Hongsheng Brush-Enterprise Co., Ltd. 1
Jiangsu Costol Commodity Co., Ltd. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer