BEUDAMED
    FDA Registration Active 🇨🇳 China

    i-Sensor H1; i-Sensor H2

    Reg #: 3005581016 · FEI: 3005581016 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
    Registration Number
    3005581016
    FEI Number
    3005581016
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Information Industrial Park, Guilin National High-Tech Zone
    City
    GUILIN CITY Guangxi
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212279

    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
    System, X-Ray, Extraoral Source, Digital MUH

    Proprietary Names

    i-Sensor H1; i-Sensor H2 Digital Intraoral X-Ray Imaging System i-Sensor1.5

    Establishment Types

    Manufacture Medical Device