BEUDAMED
    FDA Registration Active 🇨🇳 China

    ISEN Goggles

    Reg #: 3011522961 · FEI: 3011522961 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ISEN TECH.&TRADING CO., LTD.
    Registration Number
    3011522961
    FEI Number
    3011522961
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Gaoli Zhang Road, Room 302A, Floor 3, Building 11
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152727

    Owner / Operator

    Firm Name
    ISEN Tech.&Trading Co., Ltd.
    Operator Number
    10054871
    Address
    3 Gaoli Zhang Road, Room 302A, Floor 3, Building 11
    City
    Beijing
    State
    CN-BJ
    Postal Code
    100095
    Country
    CN
    Correspondent
    Zhiyong Liu

    US Agent

    Business Name
    Coland Medical Technologies, Inc.
    Contact Name
    Siran Liu
    Address
    1611 Finland Palm
    City
    San Antonio
    State
    TX
    ZIP
    78251
    Country
    US
    Email
    [email protected]
    Phone
    954 5919309

    Products

    Device Name Product Code
    Nystagmograph GWN

    Proprietary Names

    ISEN Goggles IG Pro IG

    Establishment Types

    Manufacture Medical Device