BEUDAMED
    FDA Registration Active 🇨🇳 China

    Checkme O2/SpO2oxiband sleepmonitor

    Reg #: 3019737388 · FEI: 3019737388 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Hangzhou VivaLNK Medical Technology Co.,LTD.
    Registration Number
    3019737388
    FEI Number
    3019737388
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 502, Floor 5, Building 2, No.2, 8th Avenue, Baiyang Sub-district, Qiantang District,
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191088

    Owner / Operator

    Firm Name
    VivaLnk Inc
    Operator Number
    10049171
    Address
    51 EAST CAMPBELL AVE., SUITE 160
    City
    Campbell
    State
    CA
    Postal Code
    95008
    Country
    US
    Correspondent
    quoi v huynh

    US Agent

    Business Name
    VIVALNK INC
    Contact Name
    quoi huynh
    Address
    51 EAST CAMPBELL AVE., SUITE 160
    City
    Campbell
    State
    CA
    ZIP
    95008
    Country
    US
    Email
    [email protected]
    Phone
    408 8682898

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Checkme O2/SpO2oxiband sleepmonitor

    Establishment Types

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