BEUDAMED
    FDA Registration Active 🇨🇳 China

    VacuSplint

    Reg #: 3008957229 · FEI: 3008957229 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Airflo (Xiamen) Medical Co., Ltd.
    Registration Number
    3008957229
    FEI Number
    3008957229
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1F, 3F, 4F, No. 6, East Haijing Road, Haicang
    City
    Xiamen Fujian
    Country
    CN

    Owner / Operator

    Firm Name
    Grand Healthcare Co., Ltd.
    Operator Number
    10026229
    Address
    4F, No. 49, Section 2, Jen Ai Road
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    100
    Country
    TW

    US Agent

    Business Name
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Splint, Extremity, Non-Inflatable, External, Non-Sterile NOC

    Proprietary Names

    VacuSplint EZSplint

    Establishment Types

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