BEUDAMED
    FDA Registration Active 🇨🇳 China

    Realton (Suzhou) Medical Technology Co., Ltd.

    Reg #: 3019906161 · FEI: 3019906161 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    Realton (Suzhou) Medical Technology Co., Ltd.
    Registration Number
    3019906161
    FEI Number
    3019906161
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou,
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K202601

    Owner / Operator

    Firm Name
    Realton (Suzhou) Medical Technology Co., Ltd.
    Operator Number
    10082212
    Address
    601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park
    City
    Suzhou
    State
    Jiangsu
    Postal Code
    215123
    Country
    CN
    Correspondent
    Mingzhu Liu

    US Agent

    Business Name
    OSMUNDA TECHNOLOGY CO., LTD.
    Contact Name
    Cancan Huang
    Address
    949 White River Dr Allen
    City
    Allen
    State
    TX
    ZIP
    75013
    Country
    US
    Email
    [email protected]
    Phone
    858 3571157

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Single-use sterile medical laser fiber Surgical Green Laser System FLARE™ single-use surgical laser fiber

    Establishment Types

    Manufacture Medical Device