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    FDA Registration Active 🇨🇳 China

    YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD

    Reg #: 3011193403 · FEI: 3011193403 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    37
    Establishment Types
    4
    Classifications
    21

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    Registration Details

    Registration Name
    YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD
    Registration Number
    3011193403
    FEI Number
    3011193403
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Beizhou Road, Lidian Town, Guangling District
    City
    Yangzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220292

    Owner / Operator

    Firm Name
    Yangzhou Fartley Medical Instrument Technology Co., Ltd
    Operator Number
    10047116
    Address
    Beizhou Road, Lidian Town, Guangling District
    City
    Yangzhou
    State
    Jiangsu
    Postal Code
    225106
    Country
    CN

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Cleaner, Ultrasonic, Medical Instrument FLG
    Hemostatic Metal Clip For The Gi Tract PKL
    Endoscopic Bite Block MNK
    Bedding, Disposable, Medical KME
    Endoscope Channel Accessory ODC
    Tubing/Tubing With Filter, Insufflation, Laparoscopic NKC
    Snare, Flexible FDI
    Tube, Aspirating, Flexible, Connecting BYY
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Holder, Camera, Surgical FXR
    Dislodger, Stone, Basket, Ureteral, Metal FFL
    Accessories, Cleaning Brushes, For Endoscope MNL
    Forceps, Biopsy, Non-Electric FCL
    Endoscope Introducer Kit NWU
    Lubricant, Patient KMJ
    Snare, Non-Electrical FGX
    Gauze / Sponge,Nonresorbable For External Use NAB
    Bottle, Collection, Vacuum KDQ
    Endoscopic Irrigation/Suction System OCX

    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 SmartSnare EMR Hexagonal Snare Non-woven gauze SafeSnap Polyp Trap/E-tech Polyp Trap,Non-sterile Clean Connecting Tube

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device