BEUDAMED
    FDA Registration Active 🇨🇳 China

    Arthrex Medical Device (Shanghai) Co. Ltd.

    Reg #: 3031238646 · FEI: 3031238646 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Arthrex Medical Device (Shanghai) Co. Ltd.
    Registration Number
    3031238646
    FEI Number
    3031238646
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Room C212, 2/F, West Sub-Building (Building C), Block 3, No. 88, Hedan Road, Pilot Free Trade Zone
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K153218

    Owner / Operator

    Firm Name
    ARTHREX, INC.
    Operator Number
    1220287
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    Postal Code
    34108
    Country
    US
    Correspondent
    Barry Dietz

    US Agent

    Business Name
    ARTHREX, INC.
    Contact Name
    Barry Dietz
    Address
    1370 CREEKSIDE BLVD., --
    City
    Naples
    State
    FL
    ZIP
    34108
    Country
    US
    Email
    [email protected]
    Phone
    800 9337001 ext. 76939

    Products

    Device Name Product Code
    Camera, Television, Surgical, Without Audio FWB
    Laparoscope, General & Plastic Surgery GCJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    Camera, Television, Surgical, Without Audio INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device