BEUDAMED
    FDA Registration Active 🇨🇳 China

    GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD

    Reg #: 3005581016 · FEI: 3005581016 · Expires 2026
    View on FDA
    Products
    25
    Proprietary Names
    98
    Establishment Types
    1
    Classifications
    25

    Registration Details

    Registration Name
    GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
    Registration Number
    3005581016
    FEI Number
    3005581016
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Information Industrial Park, Guilin National High-Tech Zone
    City
    GUILIN CITY Guangxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K251438

    Owner / Operator

    Firm Name
    GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
    Operator Number
    9080879
    Address
    Information Industrial Park, Guilin National High-Tech Zone
    City
    GUILIN
    State
    Guangxi
    Postal Code
    541004
    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
    Unit, X-Ray, Extraoral With Timer EHD
    Plugger, Root Canal, Endodontic EKR
    Handpiece, Direct Drive, Ac-Powered EKX
    Controller, Foot, Handpiece And Cord EBW
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Syringe, Cartridge EJI
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Locator, Root Apex LQY
    System, X-Ray, Extraoral Source, Digital MUH
    Drill, Bone, Powered DZI
    Scaler, Ultrasonic ELC
    Endodontic Kit NYD
    Instrument, Manual, Surgical, General Use MDM
    Powered Laser Surgical Instrument GEX
    Laser, Dental, Soft Tissue NVK
    Lamp, Infrared, Therapeutic Heating ILY
    Pick, Massaging JET
    Instrument, Cutting, Operative EKD
    Activator, Ultraviolet, For Polymerization EBZ
    Needle, Dental DZM
    Tester, Pulp EAT
    Handpiece, Air-Powered, Dental EFB
    Airbrush KOJ
    Instruments, Dental Hand DZN

    Proprietary Names

    Ai Ray Lite, Ai Ray Pro, Master Ray Dental X-Ray Device Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E Endo Motor, Ai- Motor, Endo Radar Plus ACE Motopex, Endo Matic, Endo Smart+, E-Com+ Endo Radar Pro, Endo Smart Smart A, Endo Pace, Endo Free, BAE380R E-COM, Endo Radar Endo Motor, EDGEAPEX HP EndoPro Ai1 812 MT Endo Space Endo Motor, CanalPro X-Move Endo Motor, Endo GT Pro Dental Implant Unit (Model: Implant-X, Implant-X LED, Implanter, Implanter LED, Implant NX, Implant Smart, Implant Air, Implant Pilot) MT2, MT3 Dental Electric Motor ES5, ES5+, ES5 Pro, ES5 Pro+ M2 Pro Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL Root Canal (Endodontic) Dental Anesthesia Device (Model: Super Pen, Star Pen) Prophylaxis Powder, Model: PT-S1, PT-S2, PT-S3 Apex Locator Woodpex V Woodpex III DPEX V DPEX III Ai-Pex Minipex COMPEX Woodpex X, Dpex X Digital Intraoral X-Ray Imaging System i-Sensor H1; i-Sensor H2 i-Sensor1.5 US-II, US-II LED,DS-II, DS-II LED Surgery-X, Surgery-X LED, Surgic Touch, Surgic Touch LED Piezo Bone Surgery Ai-surgery, Surgic smart Ultrasurgery Terauchi File Removal Kit Endo File Remover D-Laser 16, D-Laser Blue, LX 16, LX16 Plus Dental Diode Laser System Laser Smart, Laser Smart Blue Ultrasonic Endo Activate Device Endo 1, Endo 3 Gauge for Gutta-Percha-Points R1, R1 Plus U600,U600 LED;D600,D600 LED;D6,D6 LED;UDS-N6,UDS-N6 LED, V6, V6 LED Ultrasonic Periodontal Treatment Device: PT 3,PT5 U6, U6 LED, S6, S6 LED Ultrasonic Scaler,Multiple Models Sonus UDS-K LED;UDS-A LED;UDS-P LED;UDS-L LED;UDS-N3 LED;UDS-N2 LED;UDS-J2 LED;D3 LED;D5 LED;V3 LED;V2 LED UDS-A;UDS-P;UDS-E;UDS-P;UDS-E;D1;D3;D5;D7 UDS-T LED, D8 LED UDS-J;UDS-K;UDS-L;;UDS-N2 UDS-N3, V3,D7 LED;UDS-E LED Ai Ray i-Scan Imaging Plate Scanner Imaging Plate Scanner LED.E;LED.F;LED.H;LUX V, LUX E LUX VI i Led O-Light X-Cure B-Cure O-Star LED.G LED.B;LED.C,LED.D iLed II Dental Curing Light O-Light II V V Light X-Star My-Star Tips of Ultrasonic Endo Activate AP-H Plus Dental Air Polishing Handpiece AP-P, AP-P Pro AP-Mini+ AP-Mini AP-H Dental Scaler and Air Polisher UC500L PT-A, AP-A, AP-B PT-B Love Hygiene Air Dental Electric Motor, PT-A Plus PT-B mini Sharpening Tool Bits Dental Explorer Cordless Prophy System i-Polish; K-Po; Freestyle pro; promateCL Ultrapro Tx Cordless Prophy-Mini

    Establishment Types

    Manufacture Medical Device